BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6432944 · Received March 24, 2017

    Report

    Report Number
    9616066-2017-00506
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Report Date
    February 12, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML HOSPIRA BAG, NDC 0409-7983-02, LOT 61-011-JT, EXP 1 JAN 2018, 0.9% NACL INJECTION; 50ML HOSPIRA BAG NDC 0409-7923-36, LOT 64-080-JT, EXP 1 APR 2018, 5% DEXTROSE INJECTION, THERAPY DATE UNK. 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 WAS CONFIRMED. THE PRIMARY AND SECONDARY SET WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. THE CHECK VALVE WAS INSPECTED UNDER MAGNIFICATION AND NOTED TO BE ASSEMBLED IN THE SET CORRECTLY WITH THE SILICONE MEMBRANE CENTERED. FUNCTIONAL TESTING CONFIRMED BACKFLOW INDICATING A FAULTY CHECK VALVE. DISASSEMBLY OF THE CHECK VALVE RESULTED IN NORMAL FINDINGS. NO PARTICULATES WERE NOTED ON THE DIAPHRAGM MEMBRANE. THE CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNEXPECTED PRODUCT THAT WAS RETURNED WAS ASSOCIATED WITH A BACK FLOW EVENT. THE SECONDARY OF DEXAMETHASONE 20 MG/50 ML WAS TO INFUSE AT 208 ML/HR BACKFLOWED INTO THE PRIMARY OF NORMAL SALINE. ALTHOUGH REQUESTED. NO ADDITIONAL PATIENT OR EVENT INFORMATION PROVIDED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213879 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 8100,MS3500-15,8015, THERAPY DATE UNK