Medical device incident reporting and investigation scheme (IRIS) - article index
To November 2007
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
TGA News 38(2) Jul 2002 - Adverse events associated with improper or absent preparation of the chest area prior to defibrillation
TGA News 51(3) Nov 2006 - Anaesthesia - Carbon monoxide poisoning during inhalation
TGA News 36(2) Oct 2001 - Anaesthetic machine - Delivery of 100% nitrous oxide by Ulco Elite 615 anaesthetic machine
TGA News 51(1) Nov 2006 - Anaesthetic machine - Fire during cleaning procedure
TGA News 50(3) Jul 2006 - Anaesthetic machine - 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 - Arthroplasty component - Femoral Stem Fractures in Zimmer Modular Revision (ZMR®) Hip Systems
TGA News 40(2) Mar 2003 - Arthroplasty component - Stryker® Trident® PSL Acetabular Shell
TGA News 42(6) Nov 2003 - Arthroplasty component - Update: Actions on zirconia femoral head prostheses
TGA News 39(4) Nov 2002 - Arthroplasty component - Zimmer Harris Gallante (HG) polyethylene liner dissociation
TGA News 40(7) Mar 2003
B
- Battery packs - LINAK Jumbo - Risk of fires
TGA News 34(3) Feb 2001 - Bed rails - Entrapment of patient's head in the side rail of a hospital bed
TGA News 46(1) Apr 2005 - Bone cement - Complications related to the use of bone cement in Vertebroplasy and Kyphoplasty procedures
TGA News 40(1) Mar 2003
C
- Coring of rubber bungs by IV giving sets
TGA News 51(4) Nov 2006
D
- Defibrillator - External - Recall for product correction of Laerdal Patient Cable Adapters (Laerdal Cat # 920650)
TGA News 46(4) Apr 2005 - Defibrillator - External - 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 43(2) Mar 2004 - Diathermy interaction - 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
E
- 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
F
- Fluid warmers - Update on high flow fluid warmers
TGA News 40(6) Mar 2003 - Fluid warmers - Update on high flow fluid warmers
TGA News 44(4) Jul 2004
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 - Guide wires - update - Potential embolisation and/or unravelling of guide-wires following insertion of central venous catheters
TGA News 46(3) Apr 2005
H
- 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 - Heart valve - 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 - Mobile electric patient hoists
TGA News 47(3) Jul 2005 - Hoist - Patient hoist failure due to poor maintenance
TGA News 48(4) Nov 2005 - Hoist - Patient lifters: need for routine inspection, repair, maintenance and testing and careful use
TGA News 45(3) Nov 2004 - Hoist slings - Old and worn sling failure on Haycomp patient lifter
TGA News 43(1) Mar 2004
I
- 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 - Infusion pump - Alaris Medical Systems IVAC Model 591 Volumetric
TGA News 35(1) Jun 2001 - Infusion pump - CADD pumps
TGA News 49(2) Mar 2006 - Infusion pump - CADD-Legacy® PLUS pump mistaken for CADD-Legacy® 1 pump
TGA News 48(2) Nov 2005 - Infusion pump - Colleague Volumetric 2M8151K
TGA News 38(1) Jul 2002 - Infusion pump - 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 - Infusion pump - Update on Gemstar Infusion Pump Sets
TGA News 40(5) Mar 2003 - Infusion pump - 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
J
K
L
- 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 on intravenous lines
TGA News 42(5) Nov 2003 - Luer slip fittings - Potential for disconnection
TGA News 41(3) Jul 2003
M
- Maintenance of medical devices: minimisation of cross contamination
TGA News 37(2) Mar 2002 - Medical gas - Substitution of nitrous oxide for Entonox
TGA News 38(6) Jul 2002 - Monitor - Warning! MRI compatible monitors can still be drawn into the core of the scanner
TGA News 55(2) Apr 2008 - Monitor - Patient monitors can interpret pacemaker pulses as normal heart rhythm
TGA News 41(2) Jul 2003 - Monitor - Spacelabs 1700 Central Monitor alarm settings
TGA News 46(5) Apr 2005 - Monitor - Siemens SC 900 XL
TGA News 40(3) Mar 2003 - 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
N
- 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
O
- Oxygen saturation probes - Differing alarm mechanisms for reusable or single use probes
TGA News 43(3) Mar 2004
P
- 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 meters (PFMs), hand held - Clarification of Nov 2004 article
TGA News 47(1) Jul 2005 - Peak expiratory flow meters (PFMs), hand held - 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
Q
R
- 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 - Regulator - Oxygen regulator fires resulting from incorrect use of CGA 870 seals
TGA News 50(1) Jul 2006 - Regulator - Datex-Ohmeda Calibration Gas Regulators
TGA News 42(4) Nov 2003 - Reusable instruments - Contaminated loan equipment
TGA News 50(5) Jul 2006 - Reusable instruments - Kerrison Cervical Rongeurs - cleaning
TGA News 42(2) Nov 2003 - Reusable surgical instruments - Can they be adequately cleaned?
TGA News 39(1) Nov 2002
S
- Samples for testing - Protocol for sending medical devices to the TGA for testing
May 2007 - 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 - Syringes - Use of incompatible syringes in syringe drivers
TGA News 35(7) Jun 2001 - Syringes used with the Lieble Flarsheim Angiomat Power Injectors - DIR 13440
TGA News 40(4) Mar 2003
T
- Traction machine - Metron Accutrac 2 - software problem (pdf,234kb)
Australian Therapeutic Device Bulletin 42(3) Oct 2000
U
- Urinary catheter balloon size and filling capacity
TGA News 51(5) Nov 2006
V
- 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 - Ventilator - Safety alert - Warm restart due to possible electromagnetic interference by data network cables on Drager Evita ventilators
TGA News 50(2) Jul 2006
W
- 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