BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT®

    MDR report key: 19875678 · Received July 31, 2024

    Report

    Report Number
    9610825-2024-00615
    Event Type
    Death
    Date Received
    July 31, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 31, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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). 1. GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT SPACE 2.2 ARTICLE NUMBER: 8713050. 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: N030005. 2.5 HOURS OF OPERATION: 9077. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. INTERNAL REPORT OF R&D: ANALYSIS OF THE HISTORY DATA REGARDING THE DEVICE ALARM DA 2112. SERIAL NUMBER OF THE DEVICE: (B)(6). THE DEVICE ALARM DA 2112 IS LISTED ONCE IN ALARM HISTORY OF THE DEVICE: 25.06.2024 02:32:52 PM DA 2112. THE DEVICE ALARM DA 2112 IS LISTED ALSO ONCE THE DEVICE HISTORY OF THE DEVICE. ANALYSIS OF THE DEVICE HISTORY DATA: 25.06.2024 03:11 PM DEVICE SWITCHED ON. 25.06.2024 03:15 PM SYRINGE "SPACE LINE" CONFIRMED. 25.06.2024 03:15 PM AUTOPROGRAMMING ORDER WITH DRUG "NORAD8" SELECTED WITH DOSE 0.1 MCG/KG/MIN AND VTBI 100 ML. 25.06.2024 03:16 PM START INFUSION WITH RATE 3 ML/H 10 TIMES CHANGES OF THE DOSE. 25.06.2024 02:27 PRE-ALARM VTBI NEAR END. 25.06.2024 02:30 PRE-ALARM CONFIRMED. 25.06.2024 02:32 NEW VTBI 100.10 ML SET. 25.06.2024 02:32 --> DA 2112. THE DEVICE ALARM DA 2112 AFTER SETTING A NEW VTBI COULD BE REPRODUCED. THE DEVICE ALARM DA 2112 AFTER SETTING A NEW VTBI WAS ADDED TO THE JIRA DATABASE OF THE SOFTWARE DEVELOPMENT. DA 2112 AFTER CONFIRMATION OF A NEW VTBI IN THE SECOND IN WHICH THE PREVIOUS VTBI WOULD HAVE ENDED. UNFORTUNATELY, THIS DEVICE ALARM DA 2112 IS ALSO INCLUDED IN THE MOST RECENTLY RELEASED SOFTWARE 68_N030008. AS A WORKAROUND, IF A VOLUME PRE-ALARM IS PENDING, A NEW VOLUME SHOULD ONLY BE ENTERED WHEN THE INFUSION IS STOPPED. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 3.4 INDIVIDUAL INSPECTION: N/A. 3.5 DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE COULD BE FOUND LIQUID RESIDUES ON THE EMC PROTECTION SHIELD, THE LOWER HOUSING AND THE BOTTOM INNER FRAME. 3.6 TEST EQUIPMENT: N/A DESCRIPTION: N/A TYP NR.: N/A LAB.-ID.-NR. 3.7 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: INFUSOMAT SPACE LINE 8700036SP REF.: 24D21E8ST1 LOT: 4. JUDGMENT: 4.1 THE COMPLAINT COULD BE CONFIRMED. THE DEVICE ALARM DA 2112 AFTER SETTING A NEW VTBI WAS ADDED TO THE JIRA DATABASE OF THE SOFTWARE DEVELOPMENT. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: WHEN DID THE FAILURE OCCUR: DURING THERAPY. REASON OF COMPLAINT: UNIT WAS REPORTED TO AUTO SHUT DOWN AND HAVING THE ERROR MESSAGE "DEVICE..." BUT STAFF WAS UNABLE TO CAPTURE ENTIRE ERROR MESSAGE BEFORE AUTO SHUTDOWN. THIS HAPPENED ON (B)(6) 2024, AROUND 12PM ONWARDS. STAFF IS UNABLE TO PROVIDE ME WITH DOSE/RATE/VTBI. THERAPY RAN WAS NORADRENALINE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911856 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death