The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Plum A+ Family of Infusers manufactured by Hospira UK Limited. The affected list numbers are:
According to the manufacturer, there is a potential for fluid ingress into the Plum A+ mechanism assembly. This issue may result in the device being unable to recognize installed tubing or installed cassettes, or cause Valve Cassette Test Failures. Subsequently, audible and visual alarms may be triggered and lead to a delay or interruption in therapy.
Hospira explained that the severity of the problem is dependent upon the underlying condition of the patient and the treatment being prescribed. Significant injury or death can be resulted.
Hospira has identified multiple root causes for this issue, including spillage/ contamination on the pressure sensing system from IV and cleaning fluids, design robustness of the fluid shield and fluid contamination/ build-up leading to misalignment of the pressure sensor pins with the cassette disphragm.
While Hospira is carrying out remediation activities to address the problem, customers are reminded to clean the infuser weekly according to the Plum A+ System Operations Manual.
For details, please visit the following MHRA website:http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON234577
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 February 2013