Medical device incident reporting and investigation scheme (IRIS) - article index

To July 2008

From 2001, IRIS safety alerts and statistics have been included as an insert in TGA News. Prior to this, they were part of the Australian Therapeutic Device Bulletin.

Reports are alphabetised according to device type, product name and issue.

A

• Administration set
  • Gemstar Infusion Pump Administration Set
    TGA News 38(2) Jul 2002
  • Incorrect loading of the Baxter Flo-Gard IV administration set can cause blood loss
    TGA News 56(3) Jul 2008
• Adverse events associated with improper or absent preparation of the chest area prior to defibrillation
  TGA News 51(3) Nov 2006
• Anaesthesia/anaesthetic machine
  • Anaesthetic machine caught fire during cleaning procedure after use
    TGA News 50(3) Jul 2006
  • Carbon monoxide poisoning during inhalation anaesthesia
    TGA News 36(2) Oct 2001
  • Delivery of 100% nitrous oxide by Ulco Elite 615 anaesthetic machine
    TGA News 51(1) Nov 2006
  • Recall for product correction of PVC tubing in Ulco Anaesthetic Machine
    TGA News 38(5) Jul 2002
• Arthroplasty component
  • Acetabular cups - Implex Ceramic
    TGA News 41(1) Jul 2003
  • Femoral Stem Fractures in Zimmer Modular Revision (ZMR®) Hip Systems
    TGA News 40(2) Mar 2003
  • Stryker® Trident® PSL Acetabular Shell
    TGA News 42(6) Nov 2003
  • Update: Actions on zirconia femoral head prostheses
    TGA News 39(4) Nov 2002
  • Zimmer Harris Gallante (HG) polyethylene liner dissociation
    TGA News 40(7) Mar 2003

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B

• Battery packs - LINAK Jumbo - Risk of fires
  TGA News 34(3) Feb 2001
• Beds
  • Entrapment of patient's head in the side rail of a hospital bed
    TGA News 46(1) Apr 2005
  • Maintenance of hospital beds - An important issue for preventing injury to patients and staff
    TGA News 56(5) Jul 2008
  • Marshall Torrens electrically operated hospital beds - Patient safety issues
    TGA News 56(6) Jul 2008
• Bone cement - Complications related to the use of bone cement in Vertebroplasy and Kyphoplasty procedures
  TGA News 40(1) Mar 2003

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C

• Coring of rubber bungs by IV giving sets
  TGA News 51(4) Nov 2006

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D

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• Defibrillator - external
  • Recall for product correction of Laerdal Patient Cable Adapters (Laerdal Cat # 920650)
    TGA News 46(4) Apr 2005
  • SYNC/NON-SYNC behaviour of Heartstream M4735A Defibrillator
    TGA News 41(6) Jul 2003
• Dental amalgam capsules - mercury leakage during trituration - DIR 11857 (pdf,234kb)
  Australian Therapeutic Device Bulletin 42(10) Oct 2000
• Diabetes monitor - Safety alert - Abbott Medisense Optium Xceed Diabetes Monitoring System
  TGA News 48(1) Nov 2005
• Dialyser - Hollow fiber Polysynthane (PSN) dialyser (pdf,234kb)
  Australian Therapeutic Device Bulletin 42(1) Oct 2000
• Diathermy
  • Misconnection of electrosurgical bipolar electrodes
    TGA News 56(7) Jul 2008
  • Misconnection of electrosurgical bipolar electrodes
    TGA News 43(2) Mar 2004
  • Risk of injury from the interaction between active/powered implants and diathermy treatment
    TGA News 36(3) Oct 2001
• Disinfectant - Instrument grade solution - CIDEX OPA: new contraindication
  TGA News 45(1) Nov 2004
• Drainage catheter - Flexima
  TGA News 35(3) Jun 2001

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E

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• Elastomer driven drug infusors (pdf,190kb)
  Australian Therapeutic Device Bulletin 41(3) May 2000
• Endoscopy equipment - Retained biliary stent within a duodenoscope
  TGA News 48(5) Nov 2005

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F

• Fluid warmers
  • Update on high flow fluid warmers
    TGA News 40(6) Mar 2003
  • Update on high flow fluid warmers
    TGA News 44(4) Jul 2004

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G

• Gas outlets - Imitation CIG (BOC) gas outlets on ICU pendants
  TGA News 48(3) Nov 2005
• Guide wires
  • Potential embolisation and/or unravelling of guide-wires following insertion of central venous catheters
    TGA News 39(2) Nov 2002
  • Update - Potential embolisation and/or unravelling of guide-wires following insertion of central venous catheters
    TGA News 46(3) Apr 2005

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H

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• Haemostatic agents - Severe adverse events associated with the use of absorbable haemostatic agents
  TGA News 44(3) Jul 2004
• Heart valve
  • 'Single leg separation' found in recently explanted Bjork Shiley Prosthetic Heart Valve
    TGA News 41(5) Jul 2003
  • St Jude Medical Silzone - coated master series mechanical prosthetic heart valves and Silzone - coated annuloplasty rings (pdf,190kb)
    Australian Therapeutic Device Bulletin 41(1) May 2000
• High flow fluid infusers and air embolism
  TGA News 37(4) Mar 2002
• Hoist/hoist slings
  • Mobile electric patient hoists
    TGA News 47(3) Jul 2005
  • Patient hoist failure due to poor maintenance
    TGA News 48(4) Nov 2005
  • Patient lifters: need for routine inspection, repair, maintenance and testing and careful use
    TGA News 45(3) Nov 2004
  • Old and worn sling failure on Haycomp patient lifter
    TGA News 43(1) Mar 2004

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I

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• Incubators - Drager 8000
  TGA News 34(2) Feb 2001
• Infusion pump
  • Abbott "Pain Management Provider" Drug Infusion Pump - Faulty patient bolus cable
    TGA News 44(1) Jul 2004
  • Alaris Medical Systems IVAC Model 591 Volumetric infusion pump
    TGA News 35(1) Jun 2001
  • CADD pumps
    TGA News 49(2) Mar 2006
  • CADD-Legacy® PLUS pump mistaken for CADD-Legacy® 1 pump
    TGA News 48(2) Nov 2005
  • Update - CADD Legacy I and Legacy Plus Infusion Pumps Misidentification of CADD Legacy Plus pump leading to over-infusion
    TGA News 49(1) Mar 2006
  • Colleague Volumetric infusion pump 2M8151K
    TGA News 38(1) Jul 2002
  • Update on Gemstar Infusion Pump Sets
    TGA News 40(5) Mar 2003
  • Graseby® MS-16 and MS-26 Syringe Drivers
    TGA News 42(1) Nov 2003
  • Infusion pump - need for cross checking procedures during programming (pdf,234kb)
    Australian Therapeutic Device Bulletin 42(6) Oct 2000
• Insulin pen injector - Innovo
  TGA News 34(4) Feb 2001
• Insulin pump - Disetronic H-Tron and H-Tron plus
  TGA News 35(2) Jun 2001
• Insulin test strips - Glucoflex R test strips for checking blood glucose levels
  TGA News 38(3) Jul 2002
• Interaction - Device/Drug interference - Extraneal Peritoneal Dialysis Solution and Advantage II Blood Glucose test strips for Accu-Chek and Accu-Trend blood glucose monitors
  TGA News 46(2) Apr 2005
• Intra-cavitary transducers - cleaning and disinfecting
  TGA News 55(1) Apr 2008
• Intra-ocular lens - Hydroview and calcium deposits on the lens (pdf,234kb)
  Australian Therapeutic Device Bulletin 42(7) Oct 2000
• Intravenous delivery systems - Incompatibility of (pdf,113kb)
  TGA News 35(4) Jun 2001
• Investigation of incidents with medical devices that have a 'memory' or an 'event log'
  TGA News 47(2) Jul 2005
• IV giving sets - Infusion of blood through giving sets that do not have a filter
  TGA News 53(2) Jul 2007

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J

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K

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L

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• Lung function testing machines - Concern over the use of 100% oxygen on patients receiving Bleomycin Therapy (pdf,190kb)
  Australian Therapeutic Device Bulletin 41(4) May 2000
• Luer slip connectors/fittings
  • Luer slip connectors on intravenous lines
    TGA News 42(5) Nov 2003
  • Potential for disconnection of Luer slip fittings
    TGA News 41(3) Jul 2003

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M

• Maintenance of medical devices: minimisation of cross contamination
  TGA News 37(2) Mar 2002
• Medical gas
  • Medical gas - Substitution of nitrous oxide for Entonox
    TGA News 38(6) Jul 2002
• Monitor
  • Battery in a patient monitor caused a fire
    TGA News 56(2) Jul 2008
  • Warning! MRI compatible monitors can still be drawn into the core of the scanner
    TGA News 55(2) Apr 2008
  • Patient monitors can interpret pacemaker pulses as normal heart rhythm
    TGA News 41(2) Jul 2003
  • Spacelabs 1700 Central Monitor alarm settings
    TGA News 46(5) Apr 2005
  • Siemens SC 900 XL
    TGA News 40(3) Mar 2003
• MRI
  • MRI burns and other injuries - continuing to occur
    TGA News 50(4) Jul 2006
  • MRI burns and other injuries - learning from experience
    TGA News 43(4) Mar 2004
  • MRI injuries to patients with implanted neurological stimulators
    TGA News 47(4) Jul 2005

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N

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• Nebuliser
  • Nebulisers - Micro Mist® Aerosol
    TGA News 42(3) Nov 2003
  • The use of nebulisers on patients who have an endotracheal tube inserted (pdf,190kb)
    Australian Therapeutic Device Bulletin 41(5) May 2000

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O

• Oxygen saturation probes - Differing alarm mechanisms for reusable or single use probes
  TGA News 43(3) Mar 2004

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P

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• Pacemaker
  • Pacemaker - Premature end of battery life on Tempo and Meta 1256D pacemakers (pdf,234kb)
    Australian Therapeutic Device Bulletin 42(8) Oct 2000
  • Pacemaker - Rate responsive pacemakers and patient monitoring systems
    TGA News 51(2) Nov 2006
• Paracentesis/thoracentesis kits
  TGA News 37(3) Mar 2002
• Patient return electrode - Burns associated with electrosurgery
  TGA News 37(5) Mar 2002
• Peak expiratory flow meter
  • Hand held peak expiratory flow meters (PFMs) Clarification of Nov 2004 article
    TGA News 47(1) Jul 2005
  • Hand held peak expiratory flow meters (PFMs) for the assessment of pulmonary function and the self-management of asthma
    TGA News 45(2) Nov 2004
• Peripherally inserted central (venous) catheters
  TGA News 38(4) Jul 2002
• Power cord - Peaston IEC Medical Appliance Coupler, Cat P18. Manufacture 1994
  TGA News 35(5) Jun 2001
• Procedure couch - Unexpected tilting of the Australian Medical Couches OMNI 510 Procedure Couch
  TGA News 51(6) Nov 2006
• Pump injector - Central venous catheter
  TGA News 44(2) Jul 2004

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Q

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R

• Radiographic table
  • Radiographic screening table - Risk of patient or operator injury - Toshiba
    TGA News 34(1) Feb 2001
  • Radiographic tables - Possibility of injury to patient's feet or fingers when the table pedestal cover is damaged
    TGA News 39(3) Nov 2002
• Regulator
  • Multi-flow medical oxygen piston regulator - Comweld Medical Products
    TGA News 37(6) Mar 2002
  • Oxygen regulator fires resulting from incorrect use of CGA 870 seals
    TGA News 50(1) Jul 2006
  • Datex-Ohmeda Calibration Gas Regulators
    TGA News 42(4) Nov 2003
• Reusable instruments
  • Reprocessing phaco-emulisfying handpieces
    TGA News 57(1) Nov 2008
  • Reusable instruments - Contaminated loan equipment
    TGA News 50(5) Jul 2006
  • Cleanability of Kerrison Cervical Rongeurs
    TGA News 42(2) Nov 2003
  • Can reusable surgical instruments be adequately cleaned?
    TGA News 39(1) Nov 2002

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S

• Samples
  • Don't throw away your samples!
    TGA News 56(1) Jul 2008
  • Samples for testing - Protocol for sending medical devices to the TGA for testing
    May 2007
• Single use devices - Understanding the medical device package labelling symbol
  TGA News 56(4) Jul 2008
• Sleep apnoea devices
  • Sleep apnoea (CPAP and VPAP) devices being used as ventilators
    TGA News 54(1) Nov 2007
  • Sleep apnoea machine - ResMed Sullivan VPAP II and VPAP II ST
    TGA News 41(4) Jul 2003
• Supply and use of unregistered or unlisted devices
  TGA News 35(6) Jun 2001
• Syringe
  • Use of incompatible syringes in syringe drivers
    TGA News 35(7) Jun 2001
  • Syringes used with the Lieble Flarsheim Angiomat Power Injectors
    TGA News 40(4) Mar 2003

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T

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• Traction machine - Metron Accutrac 2 - software problem (pdf,234kb)
  Australian Therapeutic Device Bulletin 42(3) Oct 2000

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U

• Urinary catheter balloon size and filling capacity
  TGA News 51(5) Nov 2006

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V

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• Vaporisers: risk of simultaneous use
  TGA News 35(8) Jun 2001
• Vascular closure device - Angio-Seal
  TGA News 36(1) Oct 2001
• Ventilator
  • Flow Sensor - Evita XL - NeoFlow: Occlusion by degradation products
    TGA News 53(1) Jul 2007
  • Ventilator - Oxylog 2000 transport ventilator (pdf,190kb)
    Australian Therapeutic Device Bulletin 41(2) May 2000
  • Warm restart due to possible electromagnetic interference by data network cables on Drager Evita ventilators
    TGA News 50(2) Jul 2006

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W

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• Walking frame care and maintenance
  TGA News 43(5) Mar 2004
• Warming blankets - Correct use
  TGA News 37(1) Mar 2002
• Warming system - Mallinckrodt Warmtouch 5800 patient (pdf,234kb)
  Australian Therapeutic Device Bulletin 42(2) Oct 2000

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X-Y-Z

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