BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 7173178 · Received January 8, 2018

    Report

    Report Number
    9616066-2018-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    November 27, 2017
    Report Date
    December 12, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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

    CONCOMITANT MEDICAL PRODUCTS: 250ML BAXTER EXACTAMIX REF (B)(4), LOT NUMBER 6001137, EXP 2020-09; GREEN CUROS SWAB CAP. THE CUSTOMER¿S REPORT THAT THE LASIX INFUSED FASTER THAN EXPECTED WAS DEFINITIVELY NOT CONFIRMED. VISUAL INSPECTION (INCLUDING MICROSCOPIC) SHOWED NO DAMAGE OR ANOMALIES ON THE SET AND IT'S COMPONENTS. NO LEAKS OR OTHER ISSUES WERE OBSERVED ON THE SUSPECT PRIMARY SET DURING FUNCTIONAL AND PRESSURE TESTING. THE SET DELIVERED THE CORRECT VOLUME ACCORDING TO THE PROGRAMMED INFUSION AND THE SAFETY CLAMP FUNCTIONED AS EXPECTED WHEN THE PUMP DOOR WAS OPENED AND CLOSED. ALTHOUGH THE EVENT DESCRIPTION DID NOT INCLUDE INFORMATION ABOUT WHETHER THE LASIX WAS A PRIMARY OR SECONDARY INFUSION, THE SET WAS MATED TO A LABORATORY SECONDARY SET TO SIMULATE A SECONDARY INFUSION. DURING THIS TEST INFUSION, FLUID WAS OBSERVED TO TRAVEL PAST THE CHECK VALVE AND INTO THE PRIMARY BAG INDICATING A FAULTY CHECK VALVE. THE CHECK VALVE COMPONENT WAS SENT TO THE SUPPLIER FOR ADDITIONAL EVALUATION WHERE NO PARTICULATE OR OTHER OBSERVABLE ROOT CAUSE FOR THE CHECK VALVE ISSUE WAS IDENTIFIED. THE ROOT CAUSE THAT THE LASIX INFUSED FASTER THAN EXPECTED WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LASIX INFUSED FASTER THAN EXPECTED. NO PATIENT HARM WAS REPORTED. THE EVENT OCCURRED AFTER THE USER TROUBLESHOT AN ¿AIL¿ ALARM, AND THE MODULE DOOR WAS OPENED. THE BIOMED INTERNAL HOSPITAL INVESTIGATION IDENTIFIED NO ISSUES WITH DEVICE TESTING, AND FOUND IN THE LOG REVIEW THAT THE MODULE DOOR WAS OPEN FOR 88 SECONDS AT THE TIME OF THE EVENT. AN INVESTIGATION OF THE ADMINISTRATION SET WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15180 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1