BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 2251562 · Received August 26, 2011

    Report

    Report Number
    2183502-2011-00601
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 25, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FRN
    PMA / PMN Number
    K843772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED FOR EVALUATION BUT THE EVALUATION IS NOT COMPLETE AT THIS TIME. WHEN THE EVALUATION IS COMPLETE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT A HOMECARE PATIENT WAS RECEIVING AN INFUSION OF FLOLAN. ACCORDING TO REPORTER, THE PUMP DISPLAYED A REMAINING VOLUME OF 18.4 ML. HOWEVER, THE CASSETTE WAS FOUND TO BE FULL OF MEDICATION. ACCORDING TO REPORTER, IT APPEARED THE FULL DOSAGE HAD NOT BEEN DELIVERED AS PROGRAMMED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD MEDICATION CASSETTE RESERVOIR FRN - AMBULATORY PUMP DISPOSABLE FRN SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-7001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK