BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10155801 · Received June 15, 2020

    Report

    Report Number
    1416980-2020-03376
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 14, 2020
    Report Date
    July 17, 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

    CORRECTION MADE TO G5: PMA/510K #: K071222 (PREVIOUSLY NA).

    Additional Manufacturer Narrative · 0

    H4: THE LOT WAS MANUFACTURED FROM SEPTEMBER 04, 2019 - SEPTEMBER 09, 2019. H10: THE DEVICE WAS RECEIVED CONTAINING 20 ML OF FLUID IN THE BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE FLOW RATE WAS FOUND TO BE 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

    (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 BENZYLPENICILLIN 10800MG 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
    619030 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19J012 00085412081366

    Patients

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