BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19358882 · Received May 21, 2024

    Report

    Report Number
    9610825-2024-00423
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    May 2, 2024
    Report Date
    November 20, 2024
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. WHEN THE DEVICE WAS EVALUATED, THE REPORTED ISSUE WAS NOT OBSERVED. THE DEVICE OPERATED AS INTENDED. DELIVERY ACCURACY OF 250ML/HR AND 25ML TESTED IN SPEC AT 5 MINUTES 58 SECONDS OR 101% OF EXPECTED ACCURACY. LOG REVIEW SHOWS ON (B)(6) 2024 AND 6:21PM AN INFUSION START OF 10.42ML/HR AND 250ML (DL: TACROLIMO). ON (B)(6) 2024 AND 2:59AM A PRESSURE ALARM STOPPED THE INFUSION WITH A VOLUME INFUSED TO 89.75ML. AT 3:11AM AN INFUSION START AND AT 3:15AM A PRESSURE ALARM STOPPED THE INFUSION WITH A VOLUME INFUSED TO 90.11ML. AT 4:01AM AN INFUSION START. AT 10:26AM WITH A VOLUME INFUSED TO 156.91ML PUMP WAS PLACED ON STANDBY AND BROUGHT OUT OF STANDBY AT 10:28AM AND AN INFUSION START AT 10:31AM. AIR ALARMS OCCURRED AT 12:59PM; 1:01PM; 1:06PM AND 1:11PM FOR A VOLUME INFUSED OF 183.64ML WITH NO FURTHER INFUSIONS TAKING PLACE. PREVENTATIVE MAINTENANCE WAS PERFORMED. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE US+WIRELESS BATTERY PACK (PART # 8713051U) WAS BEING USED TO INFUSE TACROLIMUS ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, A BONE MARROW TRANSPLANT (BMT) PATIENT UNDERWENT A TACROLIMUS INFUSION AT APPROXIMATELY 13:30 PM. THE PUMP WAS PROGRAMMED TO DELIVER THE MEDICATION OVER 24 HOURS. HOWEVER, AFTER APPROXIMATELY 19 HOURS, THE BAG WAS FOUND TO BE EMPTY. REPORTEDLY, THE PUMP INDICATED THAT SIXTY-SIX (66) MILLILITERS (ML) WAS LEFT ON THE INFUSION WHEN ZERO (0) ML REMAINED IN THE BAG. THE NURSE BELIEVES THAT THE PUMP INFUSED FASTER THAN PROGRAMMED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604681 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN AVITUM AG 23383A5000 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown