BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3821540 · Received January 15, 2014

    Report

    Report Number
    9616066-2014-00028
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 28, 2013
    Report Date
    December 30, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NO: (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE BIOMED REPORTED A CHECK VALVE FAILURE: MAGNESIUM SULFATE 2GM/50ML WAS HUNG AS A SECONDARY TO INFUSE AT 25ML/HR FOR 2 HOURS. THE NURSE RETURNED TO THE ROOM ABOUT 5 MINUTES LATER AND THE BAG WAS ALMOST EMPTY, HAVING INFUSED INTO THE PRIMARY BAG OF LACTATED RINGERS. THE SET UP APPEARED TO BE CORRECT. THERE WAS NO REPORT OF PT OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40826 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY SET, MFR/MODEL/LOT #UNK| ALARIS PC UNIT, SN # UNK| ALARIS PUMP MODULE SN # UNK