BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3904967 · Received June 4, 2014

    Report

    Report Number
    9616066-2014-00501
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CAREFUSION CORPORATION
    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

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING FROM THE DISTAL SMARTSITE DURING A HEPARIN INFUSION. THE LEAK WAS DISCOVERED WITHIN 24-36 HOURS OF HANGING THE IV SET AND HEPARIN BAG. REPORTEDLY, 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 REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327911 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2426-0007 14015532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT| ALARIS PUMP MODULE, SNS: UNK