BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 12436332 · Received September 7, 2021

    Report

    Report Number
    9610825-2021-00353
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Report Date
    March 1, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE PUMP WAS NOT RETURNED FOR EVALUATION, AND THE DEVICE LOGS WERE NOT MADE AVAILABLE. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE FOR EVALUATION OR THE DEVICE LOGS. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY TO THEIR B. BRAUN ACCOUNT REPRESENTATIVE: REP STATES THAT THE CUSTOMER REPORTS THE ENTIRE AMOUNT OF DRUG IN THE IV BAG IS NOT INFUSING. STATES THAT THEY HANG THEIR CHEMO AS A SECONDARY, AND THAT WHEN THE PUMP FINISHES THE SECONDARY AND SWITCHES BACK TO THE PRIMARY, THAT THERE IS STILL SIGNIFICANT VOLUME LEFT IN THE SECONDARY BAG (AT LEAST 25-50ML) AND THAT THEY HAVE TO PROGRAM ADDITIONAL VOLUME INTO THE PUMP IN ORDER TO INFUSE THE REMAINING CHEMO. STATES THAT THIS HAPPENS WHEN USING 250ML EXCEL CONTAINER AND THE PAB BAGS, AND THAT IT HAPPENS WITH ALL THE PUMPS (NOT JUST ONE PARTICULAR SERIAL NUMBER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333786 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown