BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 21970571 · Received May 6, 2025

    Report

    Report Number
    9610825-2025-00286
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    March 16, 2025
    Report Date
    May 6, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K083689, K142596 & K191910. SAMPLE INFORMATION: INFUSOMAT SPACE, 8713050 SERIAL NO.: (B)(6). HISTORY FILES INSPECTION: THE USER REPORTED THAT HE PROGRAMMED A FLOW RATE OF 3.62ML/H TO INFUSE FOR 24 HOURS ON (B)(6) 2025. HOWEVER, THE ENTIRE VOLUME WAS INFUSED IN APPROXIMATELY 16 HOURS. AN ERROR IN THE INFUSION TIME OF -33.3% IN THE USAGE HISTORY, WE CAN SEE THAT THE USER PROGRAMMED ON (B)(6) 2025, AT 04:03:21, A FLOW RATE OF 3.62ML/H AND AT 04:03:42, A VOLUME OF 86.9ML. RESULTING IN A 24-HOUR INFUSION. THE USER STARTED THE INFUSION AT 04:06:35, ON (B)(6) 2025 AND STOPPED THE INFUSION AT 02:38:12, ON (B)(6) 2025. THE TOTAL VOLUME INFUSED WAS 81.54ML. THE TOTAL INFUSION TIME WAS 22:31:37. THE INFUSION OCCURRED EXACTLY AS PROGRAMMED AND AS PER THE USER'S ACTIONS. ON (B)(6) 2025, AT 02:42:45, THE USER PROGRAMMED THE VOLUME OF 86.9ML, DID NOT CHANGE THE FLOW RATE AND DID NOT RESET THE AMOUNT OF VOLUME ALREADY INFUSED. THE USER STARTED THE INFUSION AT 02:42:48 ON (B)(6) 2025 AND STOPPED THE INFUSION AT 18:04:14 ON (B)(6) 2025. THE TOTAL AMOUNT OF VOLUME INFUSED WAS 137.05ML. IF WE SUBTRACT THE VOLUME THAT WAS NOT RESET FROM 81.54ML, THE ACTUAL VOLUME INFUSED WAS 55.51ML. PERFECTLY COMPATIBLE WITH THE TOTAL INFUSION TIME OF 15:21:26. THE INFUSION OCCURRED EXACTLY AS SCHEDULED AND AS PER THE USER'S ACTIONS. FUNCTIONAL INSPECTION: TECHNICAL COMPLAINT: ERROR IN INFUSION TIME. PROGRAMMING TO INFUSE FOR 24 HOURS WAS INFUSED IN APPROXIMATELY 16 HOURS. AN ERROR IN INFUSION TIME OF -33.3%. FUNCTIONAL TEST: WE WILL USE THE SAME PROGRAMMING REPORTED BY THE USER. THE USER DID NOT USE THE DRUG LIBRARY. THE EQUIPMENT SHOULD PERFORM THE INFUSION ACCORDING TO THE PROGRAMMING. PROGRAMMED FLOW RATE: 3.62ML/H. PROGRAMMED VOLUME: 86.88ML. RESULTING TIME: 24H00MIN. INFUSED VOLUME: 90ML ##ERROR: +3.6%. INFUSION TIME: 24H28MIN28 #ERROR: +2.0%. RESULT: APPROVED. VISUAL ANALYSIS: EQUIPMENT HAS A NORMAL USED APPEARANCE. CONCLUSION: IN THE ANALYSIS OF THE USAGE HISTORY, THE DEPARTMENT FOUND NO EVIDENCE OF ERRORS IN THE INFUSION TIME. THE RESULTING INFUSION TIME AND VOLUME WERE PROPORTIONAL TO THE USER'S PROGRAMMING AND ACTIONS. THE FUNCTIONAL TEST RESULT SHOWED THAT THE EQUIPMENT IS WORKING CORRECTLY AND PRECISELY. TECHNICAL COMPLAINT OF INFUSION TIME ERROR OF -33.3% NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "ON (B)(6) AT 02:53, AN NPP WAS INSTALLED WITH A FLOW RATE OF 3.62 A. THE INFUSION, WHICH WAS SUPPOSED TO LAST 24 HOURS, ENDED MUCH EARLIER THAN EXPECTED. THE INFUSION LASTED APPROXIMATELY 16 HOURS." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67705 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown