The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning LifeCare PCA infusion system, manufactured by Hospira, Inc.
The manufacturer has received customer reports related to improper use of the slide clamp when the syringe (vial) is manipulated, or when stopping the infusion during delivery of medication. Failure to close the slide clamp whilst manipulating the syringe (vial) or stopping the infusion, may result in an over delivery of the medication being infused which has the potential to cause a life threatening/critical injury to the patient.
Furthermore, the manufacturer advised users to follow the labelled instructions for the correct use of the slide clamp when manipulating the syringe (vial) or when stopping infusion during delivery of fluids. Hospira is in the process of creating cautionary labels for the PCA device, which will alert clinicians to close the slide clamp prior to handling the PCA vial and to open the slide clamp before starting therapy. The manufacturer is also investigating whether a design improvement is feasible to further mitigate this risk.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON184398
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 11 September 2012