BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19570379 · Received June 19, 2024

    Report

    Report Number
    2523676-2024-00624
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Report Date
    November 13, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964294617
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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). A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. FIVE RETAINS FROM THE REPORTED LOT NUMBER WERE TESTED PER SPECIFICATION AND PASSED. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: "I AM CALLING FROM (B)(6) HOSPITAL IN (B)(6). I WAS JUST CALLING AND LEAVING A MESSAGE ABOUT A PIECE OF ABOUT A TUBING, A PRIMARY TUBING THAT JUST MALFUNCTIONED AND BOLUS AN ENTIRE BAG OF MEDICINE INTO A PATIENT. AND SO, WE KNOW IT WASN'T THE PUMP BECAUSE AFTER THAT STARTED HAPPENING, THEY, THEY CHANGED OUT THE TUBING TO NEW TUBING AND THE PUMP WAS WORKING FINE AFTER THAT, THE LOT NUMBER OF THIS TUBING IS 006-193-0315. AND I JUST WANTED TO TOUCH BASE WITH SOMEBODY TO KIND OF FIGURE OUT LIKE NEXT STEPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678021 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061930315 04046964294617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown