BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSOR

    MDR report key: 10431035 · Received August 20, 2020

    Report

    Report Number
    9610825-2020-00188
    Event Type
    Death
    Date Received
    August 20, 2020
    Date of Event
    July 24, 2020
    Report Date
    August 20, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN (B)(4). FOR THE CURRENT CASE ONLY THE DEVICE HISTORY WAS AVAILABLE. WE RECEIVED THE DEVICE HISTORY OF A PERFUSOR SPACE 8713030 WITH SERIAL NUMBER (B)(4) AND SOFTWARE VERSION (B)(4). IT COULD BE DETECTED THAT ON THE REPORTED DAY OF OCCURRENCE NO ENTRIES OF AN PUMP OPERATION WERE STORED IN THE DEVICE HISTORY. THUS THE HISTORY LOG FILES OF THE LAST TWO INFUSION THERAPIES WERE DETECTED. IT WAS POSSIBLE TO DETECT THAT ON 22ND OF JULY AT 03:21PM A SYRINGE TYPE BD PLASIPAK WAS SELECTED AND AN INFUSION WITH A FLOW RATE OF 0,5 ML/H WAS STARTED. THE INFUSION STOPPED AT THE NEXT DAY ON 07:43 AM BY AN OPEN SYRINGE HOLDER. AFTER A SYRINGE CHANGE THE INFUSION STARTED AGAIN WITH A FLOW RATE OF 2 ML/H. AT 03:58PM THE INFUSION STOPPED BY AN ALARM "SYRINGE EMPTY". NO FURTHER ABNORMALITIES COULD BE DETECTED. THE COMPLAINT COULD NOT BE CONFIRMED. DUE THE INVESTIGATION OF THE DEVICE HISTORY NO ABNORMALITIES COULD BE DETECTED AND NO PRODUCT DEVIATION COULD BE FOUND. 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 · 1

    AS REPORTED BY THE USER FACILITY BY BBM SALES ORGANIZATION IN (B)(4): "PATIENT DEATH." CUSTOMER INFORMATION: PUMP WAS USED WHILE PLACING A PACE MAKER, PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897475 PERFUSOR PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death