BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 7767696 · Received August 9, 2018

    Report

    Report Number
    9610825-2018-00159
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 14, 2018
    Report Date
    October 1, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN MELSUNGEN, GERMANY. IF WE GET NEW INFORMATION ABOUT THIS COMPLAINT, A FOLLOW UP REPORT WILL CREATE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2016018. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT: (B)(4). ASED ON THE PROVIDED LOG FILES NO FLOW DEVIATION COULD NOT BE TRACED. BECAUSE NO SAMPLE WAS PROVIDED FOR INVESTIGATION, A DETAILED INVESTIGATION OF THE ISSUE COULD NOT BE PERFORMED. ACCORDING TO THE CUSTOMER DESCRIPTION THE WRONG DOSE WAS ENTERED. THEREFORE, WE CONSIDER THE COMPLAINT AS NOT CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SINGAPORE): ENTERED VTBI 50ML AND MACHINES START TO RUN AT 1045HRS. AT 1200HRS, PAIN TEAM CAME TO REVIEW PATIENT AND THEY REALIZED THAT THE MACHINE IS RUNNING AS 1MG/HR INSTEAD OF BOLUS 1MG(MAXIMUM 10MG/HR). THE PAIN TEAM RECTIFIED THE ORDER AND MACHINE SET AS PER ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608524 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1