BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15195323 · Received August 9, 2022

    Report

    Report Number
    9610825-2022-00316
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 31, 2022
    Report Date
    August 3, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    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 MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE WAS NOT AVAILABLE. ONLY THE HISTORY DATA WAS SENT FOR INVESTIGATION. THE DEVICE HISTORY FILES WERE ANALYZED. THE HISTORY FILES AT 2022-07-31 WERE INVESTIGATED. AT 03:55 AM THE VTBI OF 250 ML, AND A RATE OF 18 ML/H WERE SET. THE INFUSION WAS STARTED AT 12:00 PM. AT 01:35 PM A PRESSURE ALARM WAS DISPLAYED (REASON FOR THAT ALARM COULD NOT BE CLARIFIED). ONE MINUTE LATER A NEW RATE OF 100 ML/H AND A NEW VTBI OF 100ML WAS SET. THEN THE INFUSION WAS STARTED. AT 02:02 PM A PRESSURE ALARM WAS DISPLAYED AGAIN (REASON FOR THAT ALARM COULD NOT BE CLARIFIED). AT 02:36 PM THE INFUSION WAS STOPPED BY REACHED THE SET VTBI OF 100ML. AT 03:02 PM A NEW RATE OF 10 ML AND A NEW VTBI OF 250 ML WAS ENTERED. THEN THE INFUSION WAS STARTED. THE INFUSION WAS STOPPED AT 04:57 PM BY PRESSING THE START/STOP BUTTON. THEN A NEW INFUSION WITH A DRUGLIB NAMED: "NUH V2.1 (31 MAY 202" WAS STARTED. FURTHERMORE, NO ANOMALIES INSIDE THE HISTORY FILES COULD BE DETECTED. THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING THE HISTORY INVESTIGATION, NO ANOMALIES COULD BE DETECTED. 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SINGAPORE: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "PUMP WAS ON SODIUM BICARBONATE INFUSION THERAPY WITH INTENDED RATE OF 18ML/HR. USER COMPLAINED OF THE PUMP HAVING THE WRONG RATE BEING USED TO INFUSE INTO THE PATIENT. BASED ON HISTORY LOG , ON THE (B)(6) 2022 , LINE NO. 3224, INFUSION THERAPY WAS ON AT 18ML/HR. ON (B)(6) 2022, LINE NO. 3227, A PRESSURE ALARM WAS TRIGGERED. AFTER THE CONFIRMATION OF THE PRESSURE ALARM, LINE NO. 3234, THE THERAPY WAS RESET AND A NEW RATE OF 100ML/HR WITH 100ML VTBI WAS ENTERED. NO DRUG LIBRARY WAS INFORMED. THE KEYED IN VTBI OF 100ML COMPLETED, WITH A NEW THERAPY OF 250ML WITH 18ML/HR WAS KEYED IN. (LINE 3265). PATIENT'S CONDITION WAS NOT AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941567 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown