BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 10329322 · Received July 27, 2020

    Report

    Report Number
    1416980-2020-04363
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    October 11, 2019
    Report Date
    July 27, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412082172
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. THIS REPORT WAS INITIALLY REPORTED TO THE FDA THROUGH VMSR REPORT # 1416980-2020-00289. THE DEVICE WAS MANUFACTURED APRIL 19-22, 2019. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH REVEALED FLUID INSIDE THE BAG THAT CONTAINED THE DEVICE, INDICATING THAT THE DEVICE HAD LEAKED. THE LOCATION OF THE LEAK COULD NOT BE DETERMINED FROM THE PHOTOGRAPH. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR LEAKED FROM AN UNSPECIFIED LOCATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792340 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19D054 00085412082172

    Patients

    Seq Age Sex Outcome Treatment
    1