BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 21218262 · Received January 23, 2025

    Report

    Report Number
    9610825-2025-00002
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Report Date
    January 29, 2025
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Removal / Correction Number
    532083-08/17/2023-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. WHEN THE DEVICE WAS EVALUATED, THE REPORTED ISSUE WAS OBSERVED. THE UPSTREAM PRESSURE SENSOR WAS REPLACED. WHILE THE REPORTED ISSUE WAS CONFIRMED, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. IN ADDITION, PLEASE NOTE ON 28AUG2023, B. BRAUN MEDICAL INC. (BBMI) SUBMITTED CORRECTION/RECALL 2532083 08/17/2023-003-C TO THE UNITED STATES FOOD & DRUG ADMINISTRATION IN ACCORDANCE WITH 21 CFR 806. BBMI WILL BE REPLACING THE UPSTREAM OCCLUSION SENSORS OF SPECIFIC SERIAL NUMBER DEVICES DUE TO THE POTENTIAL FOR FALSE OCCLUSION ALARMS.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: THE REPORTING FACILITY INDICATED THE DEVICE HAS AN ISSUE RELATED TO THE ONGOING OCCLUSION SENSOR FIELD CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439894 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 97041366K2 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown