BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10285446 · Received July 16, 2020

    Report

    Report Number
    1416980-2020-04049
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    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). H4: THE LOT WAS MANUFACTURED FROM DECEMBER 18, 2019 - DECEMBER 19, 2019. H10: THE ACTUAL SAMPLES WERE NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH WAS VISUALLY INSPECTED AND SHOWED RESIDUAL FLUID INSIDE THE DEVICE BLADDER. DUE TO THE NATURE OF THE SAMPLE, NO ADDITIONAL TESTING COULD BE PERFORMED. THEREFORE, THE REPORTED EVENT COULD NOT BE REFUTED. 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 ARE THREE (3) LARGE VOLUME INFUSORS UNDERINFUSED MEDICATION TO THE PATIENT. THE DEVICES HAD NOT ADMINISTERED THE MEDICATION COMPLETELY AFTER 27 HOURS OF DELIVER TIME AND STILL HAD A GREATER THAN 15% RESIDUAL. THE SETS WERE FILLED WITH 18000MG PIPERACILLIN / TAZOBACTAM IN SODIUM CHLORIDE 0.9%. THERE WAS NO 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
    748891 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19N028

    Patients

    Seq Age Sex Outcome Treatment
    1 PIPERACILLIN/TAZOBACTAM 18000MG| SODIUM CHLORIDE 0.9%