BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 10234334 · Received July 6, 2020

    Report

    Report Number
    1416980-2020-03774
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412082172
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED TO THE PHOTOGRAPH WHICH OBSERVED RUPTURED BLADDER. THE REPORTED CONDITION WAS VERIFIED AND DUE TO THE NATURE OF THE RETURNED SAMPLE, NO ADDITIONAL TESTING COULD BE PERFORMED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED; HOWEVER THE MOST PROBABLE CAUSE OF THE CONDITION IS A MANUFACTURING RELATED ISSUE. 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) OF 2020. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF A SMALL VOLUME FOLFUSOR RUPTURED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701682 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 20B049 00085412082172

    Patients

    Seq Age Sex Outcome Treatment
    1