BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15340971 · Received September 1, 2022

    Report

    Report Number
    9610825-2022-00362
    Event Type
    Death
    Date Received
    September 1, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 1, 2022
    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 MELSUNGEN (B)(4) INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "UNDERINFUSION (STANDSTILL WITHOUT ALARM)". "AS INFORMATION RECEIVED ON 2022/08/19 FROM CUSTOMER AND AFTER THE COMPLAINT REGISTRATION: "AT 16:19PM THE PUMP SHUTS OFF WITHOUT ALARM AND WITHOUT ANY KIND OF SIGNAL THAT IT WOULD STOP. SEVERAL EMPLOYEES PASS BY THE PATIENT'S BED, BUT NONE OF THEM NOTICE THAT IT IS TURNED OFF. ONLY ALMOST 1 HOUR LATER, THE NURSE RESPONSIBLE FOR THE PATIENT, AFTER BEING SIGNALED OF THE EVENT, NOTICES AND STARTS THE PUMP IMMEDIATELY. THE SAME THING WORKS AGAIN, AND THE NURSE MOVES BEHIND IT, NOT BEING ABLE TO SEE IF THERE WAS A CONNECTION BETWEEN THE PUMP AND THE POWER CABLE. THE PUMP REMAINS IN OPERATION FOR A FEW MOMENTS, UNTIL THE VERY UNSTABLE PATIENT PRESENTS CARDIORESPIRATORY ARREST AND RHYTHM OF ASYSTOLE, UNDERGOING A MANEUVER FOR 8', BEING CARDIOVERTED. THE PATIENT RETURNS IN A SERIOUS GENERAL CONDITION. IN ACCORDANCE WITH CUSTOMER: "PATIENT IN REFRACTORY SHOCK EVOLVING WITH CARDIORESPIRATORY ARREST AND PULSELESS ELECTRICAL ACTIVITY, USING VASOACTIVE AMINES AT MAXIMUM DOSE, UNRESPONSIVE TO MEASURES INSTITUTED TO CHANGE THE PROGNOSIS. CARDIOPULMONARY RESUSCITATION MANEUVERS NOT PERFORMED" PATIENT OUTCOME: DEATH ON (B)(6) 2022. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809279 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown