BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6956869 · Received October 17, 2017

    Report

    Report Number
    9616066-2017-01389
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Report Date
    September 19, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML BAXTER BAG NDC 0338-0049-02 LOT NUMBER Y237883 EXP DEC 18 0.9% SODIUM CHLORIDE; 250ML BAXTER BAG NDC 0338-0049-02 LOT NUMBER Y240176 EXP JAN 19 0.9% SODIUM CHLORIDE. THE CUSTOMER¿S REPORT THAT THE SECONDARY BACK FLOWED INTO THE PRIMARY BAG WAS CONFIRMED AND REPLICATED. NO ANOMALIES WERE OBSERVED ON THE SET DURING VISUAL AND MICROSCOPIC INSPECTION. FUNCTIONAL TESTING WAS PERFORMED AND FLUID BACK FLOWED FROM THE SECONDARY INTO THE PRIMARY BAG INDICATING A FAULTY CHECK VALVE. TESTING OF THE COMPONENT BY THE SUPPLIER 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 THE SECONDARY BACK FLOWING INTO THE PRIMARY BAG WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    GTIN/UDI NUMBER FOR ITEM 24010-0007T LOT 17025668 IS (B)(4). 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 THE SECONDARY OF VENOFER BACK FLOWED INTO THE PRIMARY OF NORMAL SALINE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734377 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 24010-0007T 17025668

    Patients

    Seq Age Sex Outcome Treatment
    1