BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3023259 · Received February 27, 2013

    Report

    Report Number
    9616066-2013-00145
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED CHECK VALVE FAILURE. ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED FOR INVESTIGATION. SHOULD THE SET BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH EVAL RESULTS.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT A BACK CHECK VALVE FAILED IN USE DURING AN INFUSION ON A CARDIAC CRITICAL CARE PT. THE NURSE REPORTED THAT SHE STARTED A MAGNESIUM INFUSION AT 100 ML PER HOUR VIA A SECONDARY SET AND THAT ALL THE MEDICINE WENT UP INTO THE PRIMARY IV BAG VERY QUICKLY. SHE STATED THAT THE SET UP WAS VERIFIED BY ANOTHER NURSE. SHE REPORTED NO PT HARM AND THAT SHE CHANGED OUT THE TUBING AND HUNG ANOTHER BAG RIGHT AWAY. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84966 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

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