BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 10272218 · Received July 14, 2020

    Report

    Report Number
    1416980-2020-03994
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 13, 2020
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D10, H3, H4, AND H6: H4: THE DEVICE WAS MANUFACTURED FROM SEPTEMBER 26, 2019 - SEPTEMBER 28, 2019. H10: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON THE SAMPLE AND THE FLOW RATE WAS FOUND TO BE WITHIN THE PRODUCT SPECIFICATION RANGE. BASED ON THE FUNCTIONAL FLOW TEST RESULT, THE DEVICE WAS DETERMINED TO BE CONFORMING PRODUCT. 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 THAT A LARGE VOLUME FOLFUSOR DID NOT FULLY INFUSE DURING PATIENT INFUSION; APPROXIMATELY 30% SOLUTION REMAINED IN THE DEVICE. THERE WERE NO ISSUES DURING SET UP/PRIMING, THE LINE FLUSHED WITH NO RESISTANCE, AND NO KINKS WERE OBSERVED. THE DEVICE HAD BEEN FILLED WITH 8000MG FLUCLOXACILLIN 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
    736851 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19J055 00085412080161

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 230ML SODIUM CHLORIDE 0.9%| 8000MG FLUCLOXACILLIN| 230ML SODIUM CHLORIDE 0.9%| 8000MG FLUCLOXACILLIN