BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSOR®

    MDR report key: 8464081 · Received March 29, 2019

    Report

    Report Number
    9610825-2019-00089
    Event Type
    Death
    Date Received
    March 29, 2019
    Date of Event
    September 28, 2018
    Report Date
    June 17, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEA
    UDI-DI
    04046963716745
    PMA / PMN Number
    K092313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE THE PUMP INVOLVED IN THE INCIDENT ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED, HOWEVER THE DEVICE HISTORY LOGS WERE PROVIDED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY LOGS SHOWED THAT AN INFUSION USING A MONOJECT 60CC SYRINGE WAS PROGRAMMED AT THE RATE OF 0.17 ML/H ON THE DATE REPORTED BY THE USER. FOR A THERAPY WITH THIS LARGE A SYRINGE AND THE LOW RATE PROGRAMMED IT WOULD TAKE BETWEEN 4.5 AND 6 HOURS FOR A PRESSURE ALARM TO OCCUR. BASED ON THE INFORMATION PROVIDED, THE PUMP OPERATED AS INTENDED. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: THE INFUSION WAS PREPARED AS PER PROTOCOL AND THE INFUSION WAS STARTED AT APPROX. 12:15. AT 13:05 THE NURSE NOTICED THAT THE STOPCOCK WAS IN THE "CLOSED" POSITION TOWARD THE EPINEPHRINE DRIP AND THE PUMP HAD NOT ALARMED. THE INFANT PASSED AWAY AT 14:15 THAT SAME DAY. THE DEATH WAS ATTRIBUTED TO EXTREME PREMATURITY AND SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258460 PERFUSOR® PUMP, INFUSION, PCA MEA B. BRAUN MELSUNGEN AG 8713030U 04046963716745

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death