BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 9998322 · Received April 24, 2020

    Report

    Report Number
    1416980-2020-02365
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    March 30, 2020
    Report Date
    May 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. G5: PMA/510K # CORRECTION: K071222 (PREVIOUSLY NA) H4: THE DEVICE WAS MANUFACTURED FROM DECEMBER 4, 2019 - DECEMBER 5, 2019. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED TO THE PHOTOGRAPH WHICH OBSERVED A RUPTURED BLADDER. THE REPORTED CONDITION WAS VERIFIED. THE MOST PROBABLE CAUSE OF THE CONDITION IS A MANUFACTURING RELATED ISSUE. 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 THE BALLOON OF A LARGE VOLUME INFUSOR BURST DURING PATIENT INFUSION. THE SET WAS FILLED WITH 4000MG CEFEPIME IN 0.9% SODIUM CHLORIDE SOLUTION (NACL). 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
    458311 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19N020 00085412081366

    Patients

    Seq Age Sex Outcome Treatment
    1 0.9% SODIUM CHLORIDE| 4000MG CEFEPIME