BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALALRIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6377723 · Received March 3, 2017

    Report

    Report Number
    9616066-2017-00315
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    February 5, 2017
    Report Date
    February 6, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100ML BAXTER BAG, NDC 61553-216-48, LOT 17017002S, EXP 02/16/17, CEFAZOLIN; 1000ML BAXTER BAG NDC 0338-0117-04, LOT Y221275, EXP JUL 18, LACTATED RINGERS, THERAPY DATE (B)(6) 2017. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF BACKFLOW FROM THE SECONDARY TO THE PRIMARY WAS CONFIRMED. VISUAL INSPECTION OF THE SET SHOWED NO ANOMALIES. THE CHECK VALVE WAS NOTED TO BE ASSEMBLED IN THE SET CORRECTLY WITH THE SILICONE MEMBRANE CENTERED. FUNCTIONAL TESTING CONFIRMED BACK FLOW INDICATING A FAULTY CHECK VALVE. DISASSEMBLY REVEALED A PARTICULATE OF CALCIUM CARBONATE ON THE DIAPHRAGM OF THE CHECK VALVE COMPONENT. THE ROOT CAUSE WAS IDENTIFIED AS A PARTICULATE THAT PREVENTED THE CHECK VALVE FROM FUNCTIONING PROPERLY. THE ORIGIN OF THE PARTICULATE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SECONDARY INFUSION OF ANCEF WAS PRIMED, THE PRIMARY BAG WAS LOWERED, AND WHEN THE ANCEF WAS STARTED IT WAS DRIPPING VERY FAST AND BACK FLOWING INTO THE PRIMARY BAG. THE INFUSION WAS STOPPED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159615 ALALRIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 30202E,72213N, THERAPY DATE (B)(6) 2017