BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 14342050 · Received May 9, 2022

    Report

    Report Number
    1416980-2022-02338
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Report Date
    October 4, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081373
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE DEVICE WAS MANUFACTURED FROM DECEMBER 14, 2020 - DECEMBER 15, 2020. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL LEAK TEST WAS PERFORMED WITH NO ISSUES NOTED. 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 · 0

    H4: THE CORRECT DEVICE MANUFACTURE DATE IS "JANUARY 13, 2021 - JANUARY 14, 2021", PREVIOUSLY SUBMITTED AS "DECEMBER 14, 2020 - DECEMBER 15, 2020", SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR WAS LEAKING FROM THE CENTRAL INJECTION PORT. THIS ISSUE WAS DISCOVERED IN THE DRUG STOREHOUSE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667136 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 21A016 00085412081373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown