BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR

    MDR report key: 10815799 · Received November 10, 2020

    Report

    Report Number
    9610825-2020-00297
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Report Date
    November 10, 2020
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4). THE HISTORY FILES WERE READ OUT AND ANALYZED. A FLOW DEVIATION COULD NOT BE NOT COMPREHENDED REGARDING THE HISTORY FILES. BECAUSE OF THE MISSING DATE OF INCIDENCE THE LAST THERAPY WAS ANALYZED THE FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF TEST WITH A POSITIVE RESULT. THE SYRINGE, WHICH WAS INSERT FOR FUNCTIONAL TEST, COULD BE SUCCESSFULLY IDENTIFIED AND SELECTED IN THE PUMP MENU. IT WAS POSSIBLE TO BRING THE PUMP IN OPERATION. THE DELIVERY ACCURACY OF THE PUMP WAS CHECKED (RATE 5ML/H). THE DETERMINED VALUE +0,85% WAS WITHIN SPECIFICATION (+-2%) (ACCORDING TO EN ISO 60601-2-24). A SPECIAL BOLUS TEST WAS PERFORMED. NO MALFUNCTION COULD BE DETECTED. FOR AN INSIDE INVESTIGATION THE DEVICE WAS DISASSEMBLED. IT WAS POSSIBLE TO DETECTED SOME RESIDUES OF LIQUID ON THE PCB KEYBOARD. THE COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WORKS ACCORDING THE SPECIFICATION. A PRODUCT DEVIATION COULD NOT BE DETECTED. 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 INFORMATION BY BBM SALES ORGANIZATION IN (B)(4):: "OVER INFUSION". CUSTOMER INFORMATION: PUMP WAS SET OF 1ML, BUT 44 ML WAS ADMINISTERED WRONG DOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282191 PERFUSOR PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1