BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3210801 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17711
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CAUSE OF THE REPORTED CONDITION HAS BEEN DETERMINED TO BE A USER TECHNIQUE ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR FURTHER EVALUATION AND CONTAINED 120 ML OF FLUID IN THE BLADDER. UPON REMOVAL OF THE FILL-PORT CAP, VISUAL INSPECTION CONFIRMED THE PRESENCE OF LEAKAGE/BACKFLOW COMING OUT OF THE FILL-PORT. UPON DISASSEMBLY OF THE DEVICE, A GLASS FRAGMENT WAS FOUND UNDER THE CHECK-BAND. BASED ON THE FINDING, IT WAS DETERMINED THE BACKFLOW/LEAKAGE WAS CAUSED BY GLASS FRAGMENT INTRODUCED INTO THE FLUID PATHWAY DURING FILL WITHOUT THE USE OF A FILTER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BACKFLOW WAS OBSERVED IN AN INFUSOR BEFORE USE. THE INFUSOR WAS FILLED WITH 56 ML OF 5-FU AND 100 ML OF SALINE. SINCE THERE WAS NO AMPULE INVOLVED, THE CUSTOMER DID NOT USE A FILTER DURING FILING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308911 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A007

    Patients

    Seq Age Sex Outcome Treatment
    1