BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 9934486 · Received April 8, 2020

    Report

    Report Number
    1416980-2020-02053
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 28, 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 · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : PMA/510K # CORRECTION: K071222 (PREVIOUSLY NA) THE LOT WAS MANUFACTURED FROM JUNE 27, 2019 - JUNE 28, 2019. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR OVERINFUSED DURING A PATIENT INFUSION. THE DEVICE WAS FILLED WITH 120 MLS OF ANTIBIOTIC IN 0.9% SODIUM CHLORIDE AT THE HOSPITAL. THE PATIENT WAS CONNECTED TO THE DEVICE AND DISCHARGED HOME. WHEN THE NURSE CAME TO CHANGE OVER THE DEVICE, IT WAS DISCOVERED THAT THE DEVICE HAD DELIVERED THE INFUSION IN EIGHT (8) HOURS INSTEAD OF THE EXPECTED 12 HOURS. 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
    401562 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19F035 00085412081366

    Patients

    Seq Age Sex Outcome Treatment
    1 MEROPENEM 2400MG| SODIUM CHLORIDE