BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6176002 · Received December 15, 2016

    Report

    Report Number
    9616066-2016-01834
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 2, 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: 500 ML B.BRAUN BAG NDC 0264-7800-10, LOT J6J062, EXP 01/19, 0.9% NACL INJECTION, THERAPY DATE (B)(6) 2016. ADDITIONAL INFORMATION PROVIDED: CONCOMITANT MEDICAL PRODUCTS. (B)(4). THE CUSTOMER¿S REPORT OF CHECK VALVE FAILURE WAS CONFIRMED. THE PRIMARY AND SECONDARY SET WERE VISUALLY INSPECTED FOR INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED. THE CHECK VALVE WAS INSPECTED UNDER MAGNIFICATION AND FOUND TO BE ASSEMBLED IN THE SET CORRECTLY, WITH THE SILICONE MEMBRANE CENTERED. FUNCTIONAL TESTING CONFIRMED BACK FLOW. DISASSEMBLY OF THE CHECK VALVE PART RESULTED IN DISCOVERY OF A 0.0321-INCH LONG ACRYLIC PARTICLE BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM DISK. THE ROOT CAUSE OF THE REPORTED CHECK VALVE FAILURE WAS NOT CONFIRMED. HOWEVER, AN ACRYLIC PARTICLE WAS FOUND IN THE FLUID PATH THAT COULD HAVE PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE ACRYLIC PARTICLE 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SECONDARY BAG OF HYDOXYZINE FLOWED INTO THE PRIMARY BAG WHILE BEING INFUSED THROUGH CENTRAL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826652 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR