BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3241157 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19312
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION DID NOT CONFIRM THE ISSUE. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO NONCONFORMANCES WERE OBSERVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR (SV 0.5 ML/H) DID NOT INFUSE AT ALL. THE CUSTOMER REPORTED THAT THE INFUSOR WAS FILLED WITH FLUOROURACIL. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340732 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12B065

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL