BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2950536 · Received February 5, 2013

    Report

    Report Number
    9616066-2013-00082
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF CHECK VALVE FAILURE COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LIKELY CHECK VALVE FAILURE STATING DURING AN INFUSION OF A SECONDARY, THE NURSE VISUALIZED BACK FLOW OF THE SECONDARY FLUID (MAGNESIUM) INTO THE PRIMARY BAG. THE PUMP HAD NOT ALARMED AND WAS NOT EVALUATED BY THE BIOMED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47785 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS SECONDARY SET: MODEL 72213N, LOT UNK| ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN UNK