BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10315643 · Received July 23, 2020

    Report

    Report Number
    1416980-2020-04249
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    June 20, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081366
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H3, H4 AND H6. CORRECTION TO G5: PMA/510K #. H4: THE LOT WAS MANUFACTURED FROM (B)(6) 2019 - (B)(6) 2019. 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. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND FOUND TO BE WITHIN THE PRODUCT SPECIFICATION RANGE. THE DEVICE WAS FOUND TO BE CONFORMING. 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). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. 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 INFUSOR UNDERINFUSED DURING PATIENT INFUSION. THE DEVICE HAD BEEN FILLED WITH 10800MG BENZYLPENICILLIN IN SODIUM CHLORIDE 0.9%. 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
    780393 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19M035 00085412081366

    Patients

    Seq Age Sex Outcome Treatment
    1 BENZYLPENICILLIN 10800MG IN SODIUM CHLORIDE 0.9%