BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT

    MDR report key: 12061357 · Received June 24, 2021

    Report

    Report Number
    9610825-2021-00248
    Event Type
    Death
    Date Received
    June 24, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 5, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE WAS INVESTIGATED IN OUR LABORATORY IN SAO GONZALO, BRAZIL: IT WAS ONLY POSSIBLE TO EXTRACT THE USAGE HISTORY OF EQUIPMENT NO. (B)(6), WHICH ACCORDING TO THE HISTORY WAS NOT IN USE ON (B)(6) 2021, DATE OF THE ADVERSE EVENT. EQUIPMENT Nº (B)(6) AND Nº (B)(6) HAVE THEIR "NETWORK CONNECTION SOCKET" DAMAGED, AND IT IS NOT POSSIBLE TO EXTRACT THE HISTORY. THE 03 EQUIPMENT WAS CALIBRATED BY OUR TECHNICAL ASSISTANCE AND WAS CONSIDERED APPROVED FOR USE. WE ALSO PERFORMED INFUSION SIMULATION FOR MORE THAN 48 HOURS AND WE DO NOT VERIFY THE OCCURRENCE OF ANY UNDESIRED CHANGES IN THE PROGRAMMED INFUSION PARAMETERS. WE CONCLUDE THAT ALL EQUIPMENT IS WORKING CORRECTLY.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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 · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVERINFUSION" IN ACCORDANCE WITH CUSTOMER: THIS EVENT OCCURRED ON (B)(6), FEMALE PATIENT, (B)(6), ADMITTED TO THE CTI COVID WITH COMORBIDITY, BEING TREATED WITH NORADRENALINE. THE PATIENT HAD CARDIAC ARREST AT APPROXIMATELY 8:30 PM. THE NURSE VERIFIED WHILE PATIENT IN BED THAT THE INFUSION PUMP WAS SET UP FOR 100 ML/H. THE PATIENT DIED. CLINIC ENGINEER WAS NOTIFIED AND IT HAD BEEN REQUESTED THE BOMB LOG ON (B)(6) IN THE MORNING. THE TEAM COULD NOT IDENTIFY EXACTLY WHICH BOMB WAS USED SO THEY SEPARATED 3 EQUIPMENTS THAT WERE IN USE DURING THERAPY. MANUFACTURER REPORTS 9610825-2021-00248, 9610825-2021-00249, AND 9610825-2021-00250 ARE BEING FILED FOR EACH OF THE 3 DEVICES IN USE AT THE TIME OF THE EVENT. ALL OF THESE REPORTS ARE FOR THE SAME ADVERSE EVENT WHICH RESULTED IN A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959152 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death