The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning Plum-Set IV administration sets for infusion pump and intravenous & blood transfusion, manufactured by Hospira Inc. All lots manufactured after July 2007 are affected.
Hospira has received reports, including one that resulted in a serious injury, of fluid leaking at the CLAVE secondary port of Hospira Plum-Set IV administration sets during infusion due to the breaking of the bond between the CLAVE and the secondary port of the Plum cassettes.
The breaking of the bond can manifest itself as either cracking of the bond between the CLAVE and the secondary port or the complete separation of the CLAVE from the secondary port.
Breakage of the connection or leaking of fluid may result in a delay of therapy and subsequently lead to death or permanent injury if the therapy is life-sustaining. Moreover, leakage of a caustic substance such as an oncolytic can result in short term harms such as pain or chemical burns, or long term harm such as tissue necrosis.
In order to minimize the possibility of separation or breakage of the CLAVE directly bonded to the secondary port of the Plum cassette, Hospira recommends users to follow the instructions below:
In addition, Hospira will update the Instructions for Use of the device to reflect the above recommendations and will also be working to determine a different method by which the CLAVE can be bonded to the secondary port of Plum cassettes.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON309602
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 September 2013