BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10258691 · Received July 10, 2020

    Report

    Report Number
    1416980-2020-03909
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 12, 2020
    Report Date
    August 4, 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 INFORMATION WAS ADDED TO H4 AND H6: H4: THE DEVICE WAS MANUFACTURED FROM NOVEMBER 25, 2019 - NOVEMBER 26, 2019. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 A LARGE VOLUME INFUSOR DID NOT INFUSE. THE DEVICE WAS EXPECTED TO INFUSE FOR TWENTY FOUR HOURS; HOWEVER, AFTER THE 24 HOURS THE DEVICE REMAINED FULL. THE DEVICE HAD BEEN FILLED WITH 8000MG CEFAZOLIN IN 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
    725142 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19M041 00085412081366

    Patients

    Seq Age Sex Outcome Treatment
    1 CEFAZOLIN 8000MG| SODIUM CHLORIDE 0.9%