BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODUEL ADMINISTRATION SET

    MDR report key: 4230471 · Received October 22, 2014

    Report

    Report Number
    9616066-2014-01047
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MANUFACTURER. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE RECEIVING DAPTOMYCIN 650MG IN 50ML INFUSION AT 100ML/HR IN THE MED-SURG UNIT, THE SILICONE SEGMENT STRETCHED, THEN POPPED, SPRAYING ANTIBIOTIC. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670717 ALARIS PUMP MODUEL ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ALARIS PUMP MODULE| ALARIS PCU: SN UNK