BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 22120504 · Received May 31, 2025

    Report

    Report Number
    9610825-2025-00312
    Event Type
    Malfunction
    Date Received
    May 31, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 2, 2025
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964708626
    PMA / PMN Number
    K142596
    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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INTERNAL COMPLAINT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. WHEN THE DEVICE WAS EVALUATED THE REPORTED ISSUE WAS NOT OBSERVED. TECHNICAL EVALUATION OF THE DEVICE DID NOT IDENTIFY ANY NONCONFORMANCE'S OR DEVICE PERFORMANCE PROBLEMS WHICH WOULD DIRECTLY CONTRIBUTE TO THE REPORTED EVENT. THE LOGS WERE PROVIDED FOR REVIEW. LOG REVIEW SHOWS ON (B)(6) 2025 AND 6:26AM A PRIMARY RATE OF 75ML/HR AND A PIGGYBACK INFUSION START OF 50ML/HR AND 50ML (DL: MAG 2). AT 6:27AM INFUSION WAS STOPPED WITH A VOLUME INFUSED TO 0.88ML AND AT 6:30AM DOOR WAS OPENED. 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: PATIENT WAS SCHEDULED TO RECEIVE MAGNESIUM IVPB. AFTER THE PRIMARY RN INITIATED THE INFUSION AND WHILE STILL PRESENT IN THE ROOM, SHE OBSERVED THAT THE PUMP HAD BOLUSED THE PATIENT. THE IV BAG WAS NEARLY EMPTY, AND THE CLAMP WAS IN PLACE. THE PATIENT REMAINED STABLE. THE PUMP AND IV TUBING HAVE BEEN SEQUESTERED. PLEASE ADVISE ON THE NEXT STEPS REGARDING THE PUMP AND IV TUBING." ACCORDING TO INTEGRATION INTERFACE MESSAGES, THE NURSE ENCOUNTERED A 10005 TIMEOUT ERROR WHEN ATTEMPTING TO AUTO-PROGRAM MAGNESIUM AS A SECONDARY ON PUMP 807962, SO MANUAL PROGRAMMING POSSIBLE. PUMP AND IV TUBING SEQUESTERED IN SFH BIOMED DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844431 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 97023424I1 04046964708626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown