BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6175635 · Received December 15, 2016

    Report

    Report Number
    9616066-2016-01829
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 6, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML BAXTER BAG NDC (B)(4), LOT Y202267, EXP DEC 2017, 0.9% NACL INJECTION; 100ML BAXTER BAG (B)(4), LOT P324969, EXP MAR 2018, MEROPENEM; (2)NON-BD GREEN SWAB CAPS, THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT OF A CHECK VALVE FAILURE WAS NOT CONFIRMED. THE PRIMARY AND SECONDARY SETS WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. THE CHECK VALVE WAS INSPECTED UNDER MAGNIFICATION AND WAS NOTED TO BE ASSEMBLED IN THE SET CORRECTLY WITH THE SILICONE MEMBRANE CENTERED. FUNCTIONAL TESTING RESULTED IN NO EVIDENCE OF BACKFLOW. DISASSEMBLY OF THE CHECK VALVE RESULTED IN NORMAL FINDINGS. NO PARTICULATES WERE OBSERVED ON THE DIAPHRAGM MEMBRANE. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MEDICATION INFUSED FROM THE SECONDARY BAG INTO THE PRIMARY BAG. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825420 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1