BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10453947 · Received August 26, 2020

    Report

    Report Number
    1416980-2020-05191
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 30, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412579399
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D10, H3, H4 AND H6: H4: THE LOT WAS MANUFACTURED FROM DECEMBER 16, 2020 - DECEMBER 17, 2020. H10: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE WHICH DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. AFTER THE LUER CAP WAS REMOVED, EVIDENCE OF CONTINUOUS FLOW WAS OBSERVED AT THE DISTAL LUER. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND FOUND TO BE WITHIN THE PRODUCT SPECIFICATION RANGE. THE DEVICE WAS FOUND TO BE CONFORMING PRODUCT. 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

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO FLOW OF MEDICATION THROUGH A LARGE VOLUME INFUSOR. AFTER 48 HOURS FROM ADMINISTRATION, IT WAS OBSERVED THAT THE INFUSOR WAS FULL AND HAD NOT DELIVERED ANY MEDICATION TO THE PATIENT. THE DEVICE HAD BEEN FILLED WITH 5-FLUOROURACIL EBEWE. TO RESOLVE THE ISSUE, THE UNIT WAS REPLACED WITH A NEW ONE AND TREATMENT WAS RESUMED. 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
    921743 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19N023 00085412579399

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL EBEWE.| 5-FLUOROURACIL EBEWE