BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT®

    MDR report key: 12706843 · Received October 27, 2021

    Report

    Report Number
    9610825-2021-00443
    Event Type
    Death
    Date Received
    October 27, 2021
    Date of Event
    September 23, 2021
    Report Date
    March 1, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS INSPECTED AND TESTED AND THE REPORTED ISSUE WAS NOT PRESENT DURING THE INVESTIGATION. THE LOG REVIEW SHOWS CONTINUING INFUSIONS FROM (B)(6) 2021 AND 9:53AM A NEW VTBI SET TO 40.0ML (DL: VASOP40; RATE = 6ML/HR), THIS CONTINUED THROUGH THE TIME OF INCIDENT 2:33-3:45PM ON (B)(6) 2021 WITH AIR BUBBLE ALARM OCCURRING AT 3:45PM AND AN INFUSION START AT 3:48PM. INFUSIONS CONTINUED AND WERE STOPPED AT 4:43PM. LOG SHOWS NO DEVICE ALARMS ON (B)(6) 2021. NOTE: MAINS POWER OFF AT (B)96) 2021 AND 2:31PM AND ON AT 4:05PM. THE ABOVE TIMES ARE ACTUAL. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). PUMP LOG REVIEW INDICATED THAT THE PUMP (611632) INFUSED CONTINUOUSLY DURING TRANSPORT AND ALARMED FOR "AIR BUBBLE" ON ARRIVAL TO THE ICU AT 15:45. THE ALARM WAS ACKNOWLEDGED BY THE USER AND THE INFUSIONS WERE RESTARTED. THE DATA SUPPORTS THAT THE PUMPS OPERATED AS INTENDED AND THERE IS NO INDICATION OF ANY PUMP MALFUNCTION THAT CONTRIBUTED TO THE PATIENT OUTCOME AT THIS TIME. THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: THE PATIENT WAS TAKEN TO THE CATH LAB EMERGENTLY ON (B)(6) 2021 AT 1433 (CST), PER CHART. PATIENT TRANSPORTED FROM CATH LAB TO ICU AT 1532 (CST). THE CATH LAB IS ON THE SECOND FLOOR AND THE ICU SHE WAS GOING TO IS ON THE 3RD FLOOR. PER THE CHART, SHE ARRIVED TO ICU AT 1545 WITH NO PULSE, NO BP AND THE NURSE NOTICED THE PUMPS WERE ALL ALARMING AND PAUSED. SHE EXPIRED AT 2117 ON (B)(6) 2021 (CST). WE ARE TRYING TO DETERMINE WHETHER THE PUMPS WERE MANUALLY PAUSED, AIR IN THE LINES, OR WHAT IN THE 13 MINUTES IT TOOK TO TRANSPORT HER FROM ONE AREA TO ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600816 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 96990691I9 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death