BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 11177849 · Received January 15, 2021

    Report

    Report Number
    1416980-2020-08511
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Report Date
    February 9, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412080161
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO A2: DATE OF BIRTH: 10/18/1946 (PREVIOUSLY SUBMITTED AS NI) CORRECTION MADE TO D5: OPERATOR OF DEVICE: LAY USER/PATIENT (PREVIOUSLY SUBMITTED AS OTHER) ADDITIONAL INFORMATION WAS ADDED TO B5, D10, H3, H4 AND H6. B5: THE AFFECTED PRODUCTS IS NINE (9), PREVIOUSLY SUBMITTED AS EIGHT (8). H4: THE LOT WAS MANUFACTURED FROM AUGUST 24, 2020 ¿ AUGUST 25, 2020. H10: NINE (9) ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION CONTAINING 79, 78, 80, 77, 76, 74, 80, 78 AND 75 ML OF FLUID IN THE BLADDER. VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON ALL SAMPLES AND THE FLOW RATES WERE WITHIN THE PRODUCT SPECIFICATION RANGE. THE REPORTED CONDITION WAS NOT VERIFIED. 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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED EIGHT (8) LARGE VOLUME FOLFUSOR UNDERINFUSED. DURING EACH INFUSION, APPROXIMATELY 90% OF THE SOLUTION WAS INFUSED; LEAVING ABOUT 10% REMAINING IN THE DEVICE. THE DEVICE HAD BEEN FILLED WITH 18000MG PIPERACILLIN/TAZOBACTAM IN 230ML 0.9% SODIUM CHLORIDE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75285 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 20H027 00085412080161

    Patients

    Seq Age Sex Outcome Treatment
    1