BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MOFULE ADMINISTRATION SET

    MDR report key: 6569467 · Received May 16, 2017

    Report

    Report Number
    9616066-2017-00792
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 4, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-CFN BAG ACCESS; 500ML B. BRAUN BAG NDC 0264-7800-10, LOT J6P163, EXP 5/19, ETOPOSIDE (VEPESID) IN 0.9% NACL; 250ML B.BRAUN BAG, NDC 0264-7800-20, LOT J5N172, EXP 10/17, 0.9% NACL INJECTION; BBRAUN SECONDARY TUBING, THERAPY DATE (B)(6) 2017. GTIN NUMBER FOR ITEM 2429-0500 LOT 16118389 IS (B)(4). THE PRIMARY AND SECONDARY SET WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. POCKETS OF AIR WERE NOTED IN THE SECONDARY SET AS REPORTED. FUNCTIONAL TESTING RESULTED IN FLUID FLOWING THROUGHOUT THE SETS WITH NO OCCLUSION NOTED. AN INCIDENTAL FINDING OF A CHECK VALVE FAILURE ON THE PRIMARY SET WAS NOTED. DISASSEMBLY OF THE CHECK VALVE RESULTED IN NORMAL FINDINGS. NO PARTICULATES WERE NOTED ON THE DIAPHRAGM MEMBRANE. THE CUSTOMER¿S REPORT OF THE PRIMARY SET NOT FLUSHING COULD NOT BE CONFIRMED AS NO OCCLUSIONS WERE NOTED DURING TESTING. THE CUSTOMER¿S REPORT OF FLUID LEFT IN THE SECONDARY MEDICATION BAG COULD NOT BE CONFIRMED. THE CHECK VALVE FAILURE IS CONSIDERED AN INCIDENTAL FINDING AS IT WOULD NOT HAVE CONTRIBUTED TO FLUID BEING LEFT IN THE SECONDARY MEDICATION BAG. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT WHEN A SECONDARY INFUSION OF ETOPOSIDE WAS COMPLETED, ¿THE PRIMARY BAG DID NOT START FLUSHING THE LINE.¿ IT WAS LATER REPORTED THAT WHEN THE NURSE ARRIVED AT THE PATIENT¿S BEDSIDE, THERE WAS STILL EXTRA FLUID IN THE MEDICATION BAG (PRESUMED TO MEAN THE SECONDARY ETOPOSIDE BAG) AND THEN THE PUMP STARTED TO ALARM FOR AIR IN THE LINE. PRIOR TO THIS THE PUMP HAD NOT SWITCHED FROM THE SECONDARY TO THE PRIMARY INFUSION. THE NURSE ¿OPENED THE CHAMBER¿ (PRESUMED TO MEAN OPENING THE DOOR) AND NOTED VERY LARGE AIR BUBBLES WHICH PREVENTED THE NURSE ¿FROM BEING ABLE TO FLUSH THE PATIENT'S LINES.¿ ALTHOUGH REQUESTED, FURTHER CLARIFICATION OF THE EVENT WAS NOT PROVIDED. THERE WAS NO REPORT OF ANY PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350263 ALARIS PUMP MOFULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2429-0500 16118389

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 8015,MP1000-C,8100, TD (B)(6) 2017