BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6946492 · Received October 12, 2017

    Report

    Report Number
    9616066-2017-01318
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 21, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT THE SECONDARY BACK FLOWED INTO THE PRIMARY BAG WAS CONFIRMED AND REPLICATED. NO ANOMALIES WERE OBSERVED DURING VISUAL INSPECTION. INSPECTION UNDER MAGNIFICATION SHOWED THE CHECK VALVE WAS ASSEMBLED CORRECTLY, AND THE SILICONE MEMBRANE WAS CENTERED. FUNCTIONAL TESTING RESULTED IN BACKFLOW INDICATING A FAULTY CHECK VALVE. SUPPLIER TESTING OF THE RETURNED PART INDICATED A PASS RESULT. DISASSEMBLY OF THE CHECK VALVE RESULTED IN NORMAL FINDINGS. NO PARTICULATES WERE NOTED ON THE DIAPHRAGM MEMBRANE. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML BAXTER (B)(4), LOT NUMBER Y243394, EXP (B)(6), 0.9% SODIUM CHLORIDE; A POSITIVE BLOOD BAG. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A BLOOD TRANSFUSION, THE BACK CHECK VALVE ALLOWED BLOOD FROM THE SECONDARY BAG TO FLOW INTO THE PRIMARY TUBING. THIS OCCURRED TWICE ON THE SAME PATIENT ON THE SAME DAY WITH TWO DIFFERENT SETS. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING A SECONDARY BLOOD TRANSFUSION IT WAS NOTED THAT BLOOD BACK FLOWED FROM THE SECONDARY TO THE PRIMARY PAST THE CHECK VALVE. IT WAS REPORTED THAT THE EVENT OCCURRED TWICE IN ONE DAY ON THE SAME PATIENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725906 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1