Hospitals and other healthcare facilities are advised that, while Hospira Australia is making progress in implementing corrective actions to address the issues outlined below, new infusion pumps from the Plum A+ family still cannot be supplied in Australia.
New Plum A+ family infusion pumps cannot be supplied in Australia until the CE certificate is reinstated and the TGA receives confirmation that they comply with the Essential Principles and Conformity Assessment Procedures for medical devices, as set down in Therapeutic Goods Act 1989.
In the process of undertaking actions to bring its quality management system back into compliance, Hospira has identified two new recall actions (RC-2014-RN-00140-1 and RC-2014-RN-00152-1) involving these devices.
Hospitals and other healthcare facilities are advised that the Plum family, GemStar and LifeCare infusion pumps sponsored by Hospira Australia are subject to multiple recall actions relating to safety issues.
Hospira Australia, in consultation with the TGA, is undertaking numerous corrective actions to address the safety risks associated with these infusion pumps and has written to hospitals and other healthcare facilities providing further information on each problem (see Information for health professionals, hospitals and other healthcare facilities below).
These infusion pumps are used primarily in hospitals and other healthcare facilities, such as nursing homes and palliative care facilities, to administer medications, fluids or nutrients to patients. A small number of these devices are used in other settings, including the patient's home.
The CE certificate issued under the European Union Medical Device Directive (MDD) 93/42/EEC for the above infusion pumps was suspended on 28 February 2013 and subsequently expired on 31 August 2013. The CE certificate indicates that the medical devices conform to requirements of the MDD, which is similar to Australian medical devices legislative framework. The CE certificate was used for the inclusion of Hospira infusion pumps in the Australian Register for Therapeutic Goods (ARTG) for market authorisation in Australia.
Until the CE certificate is reinstated, Hospira Australia is unable to supply new infusion pumps to the Australian market. The TGA will consider whether new infusion pumps manufactured before this date can be supplied to the Australian market if Hospira can demonstrate compliance with the Essential Principles and Conformity Assessment Procedures, as well as show a clinical need for these pumps in Australian healthcare facilities. However, as the withdrawal of the CE certificate only affects the infusion pumps, Hospira Australia can continue to supply consumables for infusion pumps already in use.
Hospira Australia has provided hospitals and other healthcare facilities instructions for temporary actions they should implement to allow continued use of the infusion pumps where it is necessary for the treatment of patients.
The TGA continues to monitor these issues and is overseeing Hospira Australia's implementation of corrective actions in relation to Plum A+ and Plum A+3 infusion pumps.
Hospira has announced that they will be retiring GemStar, Plum XL family and LifeCare models of infusion pumps.
Information for health professionals, hospitals and other healthcare facilities
Hospira Australia has written to hospitals and other healthcare facilities to provide further information about the recalls, corrective actions and, in some cases, temporary actions that health professionals should take to address these issues and minimise risks to patients.
Generally, health professionals are advised to use an alternative infusion pump, where possible. If an alternative infusion pump is not available, you are advised to assess the risks and benefits associated with the use of any Plum family, GemStar or LifeCare infusion pump for each individual patient.
Hospira Australia has advised customers of commercial terms for transition from GemStar to a new ambulatory pump platform, Sapphire infusion pumps manufactured by Q Core. In the meantime, Hospira Australia has provided hospitals and other healthcare facilities instructions for temporary actions they should implement. The Sapphire pump offer is optional and hospitals and other healthcare facilities can choose to make different arrangements.
Below is a list of recall actions relating to Plum family, GemStar or LifeCare infusion pumps that appear in the TGA's System for Australian Recall Actions (SARA). Some of these recall actions have been completed by Hospira and are awaiting final review by the TGA. See the individual SARA entries for the current status of each recall action.
Plum family of infusion pumps:
- Recall for product correction:
- communication engine issues in downloading custom drug library (RC-2014-RN-00140-1)
- door roller assembly breakage - Plum LifeCare 5000 Series and Plum XL family (RC-2013-RN-01288-1)
- switch port labelled incorrectly (RC-2013-RN-01268-1)
- displaying E321 error code due to battery not fully charging (RC-2013-RN-00190-1)
- distal pressure sensor pin fracture (RC-2013-RN-00189-1)
- distal pressure sensor calibration drift (RC-2013-RN-00188-1)
- fluid shield diaphragm out of specification (RC-2013-RN-00180-1)
- door roller assembly breakage - Plum A+ family (RC-2012-RN-01281-1)
- volume control knob reversed (RC-2012-RN-01039-1)
GemStar infusion pumps and accessories:
- Recall for product correction:
- beeper subassembly connection issue identified as beeper error X100 (RC-2014-RN-00152-1)
- failure of pump to power up and displaying error code 11/003 due to issues with docking station (RC-2013-RN-01251-1)
- default keypad lock code compromised (RC-2013-RN-01218-1)
- battery voltage level drop (RC-2013-RN-00248-1)
- proximal and distal pressure sensor calibration drift (RC-2013-RN-00247-1)
- motor assembly roll back (RC-2013-RN-00246-1)
- battery leakage (RC-2013-RN-00245-1)
- Recall:
LifeCare patient-controlled analgesia infusion pumps:
- Recall:
- Recall for product correction:
Additionally, there are four further recall actions that have not been published in SARA, as they were initiated before 1 July 2012, the date from which recall actions were included in SARA. Details of those recall actions are below:
- Recall for product correction: Plum A+ pump versions 11.6 and 13.4 (Med Net ABG Driver) and Plum A+3 pump version 13.4 - incorrect seating of the regulator closer and continuous rebooting and/or recycling when contrast and/or backlight intensity settings for the LCD have been adjusted from the default settings (RC-2011-RN-00956-3).
- Recall for product correction: All Plum A+ family of infusion pumps and all Plum XL family of infusion pumps - failure of the piezo electric assembly resulting in no audible alarm sounding during an alarm condition, although the pump appropriately stops and displays a visual alarm (RC-2011-RN-00204-3).
- Recall for product correction: All Plum A+ family of infusion pumps - fluid ingress into the mechanism assembly, which could result in the device being unable to recognise installed tubing or cassettes, or cause valve cassette test failures (the corrective actions are being undertaken as part of RC-2011-RN-00204-3).
- Recall for product correction: GemStar bolus cords - bolus delivery failures, such as unrequested bolus delivery or failure to delivery requested medication (RC-2012-RN-00283-3).
The TGA is monitoring the implementation of these recall actions.
If you have any questions or concerns regarding any of the above recall actions, contact Hospira Australia on 1300 046 774 (option 1).
Information for consumers
Plum family, GemStar and LifeCare infusion pumps are used primarily in hospitals and other healthcare facilities, such as nursing homes and palliative care facilities by trained health professionals. A small number of these devices are used in other settings, including the patient's home.
If you have any questions or concerns about infusion pumps, talk to a health professional, such as a nurse or doctor.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.