The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Plum A+ Family of Infusers, manufactured by Hospira, Inc.
Hospira issued a field safety notice to inform users that the door roller assembly on the Plum A+/A+3 infuser family has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. The IV administration set's cassette contains a flow regulator that is designed to close upon cassette removal to prevent accidental flow. In the event the door roller assembly is broken the regulator closer may not close properly and unrestricted flow and/or over-delivery can occur which has the potential to contribute to life-threatening adverse events.
To correct the issue,Hospira has redesigned the door roller to improve the strength and reduce the potential for the door roller assembly to break and will arrange a replacement to affected customers for the door rollers. Until the door assembly is replaced, the manufactureradvisesthe users to inspect the door roller assembly prior to loading a cassette for signs of damage.If the door roller or axel appears loose, broken, or missing, then the device needs to be taken out of services until the door assembly is replaced with a corrected door assembly.
Furthermore, Hospirarecommendsthe users to keep the cassette door securely closed while the product is not in use to avoid cassette door damage. Additionally, to avoid the accidental flow, close the slide clamp or CAIR roller clamp on the administration set prior to opening the door.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON216883
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 9 January 2013