BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3820790 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00443
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2014. INTERNAL FILE NO: (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE PRODUCT BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING FROM THE SMARTSITE THAT IS JUST BELOW THE PUMP MODULE DURING HEPARIN INFUSION. THE SMARTSITE BLUE PISTON WAS NOTED TO BE DISLODGED FROM THE TOP OF THE SMARTSITE BODY. THE LEAK WAS DISCOVERED WITHIN 24-48 HR OF HANGING THE IV SET AND HEPARIN BAG. THERE WAS NOTHING PIGGYBACKED OR INJECTED INTO THE SMARTSITE PRIOR TO THE LEAK BEING NOTICED. THE SET WAS CHANGED OUT AND THE HEPARIN INFUSION CONTINUED WITH NO PROBLEMS. THERE WAS NO PT HARM OR MEDICAL INTERVENTION REQUIRED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258968 ALARIS PUMP MODULE ADMIN SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT & ALARIS PUMP MODULE: SN UNK