BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 5499035 · Received March 14, 2016

    Report

    Report Number
    9616066-2016-00397
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 13, 2016
    Report Date
    February 22, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: IV BAG OF NORMAL SALINE; THERAPY DATE (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG 2B1324, NDC (B)(4), DIN (B)(4), LOT NUMBER C992891, EXP APR 2017 OF SODIUM CHLORIDE INJECTION USP; BAYER HEALTHCARE 250ML, NDC (B)(4), LOT NUMBER BXA6EG6, EXP AUG 2018, MMFD AUG 2015 OF AVELOX IV (MOXIFLOXACIN HCI IN NACI INJECTION) 400MG/250ML 0.8% SALINE; THERAPY DATE: (B)(6) 2016. THE CUSTOMER¿S REPORT OF BACKFLOW INTO THE SECONDARY TO PRIMARY WAS CONFIRMED. TESTING OF THE RETURNED PART INDICATED A FAIL RESULT PER SUPPLIER. DISASSEMBLY OF THE CHECK VALVE PART RESULTED IN DISCOVERY OF A PARTICLE LOCATED BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM DISK. THE SIZE OF THE PARTICLE WAS MEASURED TO BE 0.0366¿ LONG. THE PARTICLE WAS IDENTIFIED AS PVC. THE ROOT CAUSE OF THE CHECK VALVE FAILURE IS DUE TO A PVC PARTICLE FOUND IN THE FLUID PATH THAT PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE PVC WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS RECEIVING AVELOX 400 MG IN 250ML TO INFUSE OVER 60 MIN AT A RATE OF 250CC PER HR. THE USER NOTICED THAT THE SECONDARY INFUSED INTO THE IV BAG OF NORMAL SALINE. THERE WAS 104 ML OF THE AVELOX REMAINING. THE INFUSION WAS STOPPED AND IV PUMP AND TUBING WAS REMOVED. NO PATIENT HARM REPORTED. EVENT OCCURRED ON THE MED/ SURG FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155851 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0500 16016362

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR