BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2221921 · Received August 17, 2011

    Report

    Report Number
    2016493-2011-00470
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 27, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED UNDER INFUSION. THE CUSTOMER STATED THE SET AND DEVICES WERE NOT SEQUESTERED, AND THEREFORE NO PRODUCTS WILL BE RETURNED FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDER INFUSION. THE CUSTOMER STATED THAT GAMMA GUARD (IVIG) 400 ML WAS TO INFUSE OVER 4 HOURS BUT AFTER 4 HOURS, 100 ML REMAINED IN THE BAG. THE IVIG WAS PREPARED BY INJECTING 2 # 200 ML VIALS OF GAMMA GUARD INTO AN IV BAG SO THE TOTAL VOLUME IN THE BAG WAS 400 ML. THE CUSTOMER DENIED ANY OVER FILL. THE INFUSION WAS STARTED SLOWLY AT 25 ML/HR FOR 15 MINS, INCREASED TO 50 ML/HR FOR 15 MINS, AND INCREASED TO 150 ML/HR FOR THE REMAINDER OF THE INFUSION. AFTER 4 HOURS, THE VTBI WAS ADJUSTED AND THE REMAINING 100 ML WAS INFUSED. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT THE USER PROVIDED NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL AND LOT # UNK| ALARIS PUMP MODULE ADMINISTRATION SET:| ALARIS PC UNIT: S/N UNK