BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 16867653 · Received May 4, 2023

    Report

    Report Number
    9610825-2023-00158
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    March 20, 2023
    Report Date
    September 14, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 400595286. THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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.

    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. 2. RESULTS: 2.1 THE DEVICE HISTORY FILES WERE ANALYZED. THE HISTORY FILES OF 2023-03-20 WERE INVESTIGATED. AT 09:23 AM THE CUSTOMER INSERTED A B.BRAUN OPS 50 ML. THE SYRINGE WAS MOUNTED ON 50 ML (VOLUME). THEN THE RATE WAS SET TO 4 ML/H AND VTBI WAS SET TO 54,4 ML. THE INFUSION WAS STARTED AT 09:23 AM. THE INFUSION WAS STOPPED AT 11:52 AM. UP TO THAT TIME THE DEVICE HAS DELIVERED A VOLUME OF 9,95 ML. IN THE SAME MINUTE THE CUSTOMER CHANGED THE RATE TO 5 ML/H AND THE TIME TO 00:30 HH:MM. THAT PRODUCED A RATE OF 82,9 ML/H (VTBI:41,45 ML / 0,5 HOURS = RATE = 82,9 ML/H). THEN THE INFUSION WAS STARTED. THE VOLUME WAS DELIVERED CORRECTLY. NO ANOMALIES COULD BE DETECTED IN THE HISTORY FILES. 3. JUDGMENT: 3.1 THE COMPLAINT COULD NOT BE CONFIRMED. THE COMPLAINT MALFUNCTION IS DUE TO A WRONG USER HANDLING. INSIDE THE SYRINGE A REST OF 41,45 ML LIQUID WAS STILL THERE. THEN THE TIME WAS SET TO 30 ML. THAT PRODUCED A RATE OF 82,9 ML. 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 (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM: "OVERINFUSION". ACCORDING TO THE CUSTOMER: "USER FROM GNH HAS ASKED MEDICAL TECHNOLOGY TO LOOK AT THE LOG FILES OF THE DEVICE TO SEE IF THERE WAS AN INPUT ERROR BECAUSE AN OPS 50 SYRINGE WAS EMPTIED WITHIN 30 MINUTES DURING A THERAPY ON 21.03.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859051 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown