BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR

    MDR report key: 10648282 · Received October 8, 2020

    Report

    Report Number
    9610825-2020-00243
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    October 27, 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 · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE INVESTIGATION OF THE COMPLAINED DEVICE WAS PERFORMED IN THE SERVICE REPAIR SHOP (B)(6), GERMANY. THE DEVICE HISTORY WAS READ OUT AND ANALYZED. DURING THE INVESTIGATION OF THE DEVICE HISTORY IT WAS POSSIBLE TO DETECT THAT THE ERROR "BRAKE-CLOSE-ERROR" AND "KPS-ERROR" OCCURRED. BOTH ERRORS ARE IN CONNECTION WITH A FALL DAMAGE, WHICH WAS CONFIRMED BY CUSTOMER. THE SAMPLE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. DURING THE VISUAL INSPECTION OF THE PERFUSOR SPACE, THE TECHNICIAN SEAL ON THE LOWER HOUSING AS WELL AS ALL COVER CAPS OF THE SCREW PILLARS WERE AVAILABLE AND UNDAMAGED. NO VISIBLE DAMAGES COULD BE DETECTED. THE FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF TEST WITH A POSITIVE RESULT. DURING THE MOVEMENT OF THE DRIVE, IT WAS POSSIBLE TO RECOGNIZED A LOUD UNUSUAL NOISY. AFTER INSERTED A SYRINGE, WHICH WAS INSERT FOR FUNCTIONAL TEST, AN ERROR "REPEAT SYRINGE CHANGE" WAS OCCURRED. THE ERROR MESSAGE COULD BE CONFIRMED AND IT WAS POSSIBLE TO BRING THE PUMP IN OPERATION. THE DELIVERY ACCURACY OF THE PUMP WAS CHECKED (RATE 5ML/H). THE DETERMINED VALUE -+0,97% WAS WITHIN SPECIFICATION (+-2%) (ACCORDING TO EN ISO 60601-2-24). FOR AN INVESTIGATION OF THE INSIDE THE DEVICE WAS DISASSEMBLED. NO DAMAGES COULD BE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. NO TECHNICAL MALFUNCTION COULD BE DETECTED DURING THE INVESTIGATION OF THE DEVICE HISTORY AND THE MEASUREMENT OF THE DELIVERY. THE DEVICE WORKS ACCORDING THE SPECIFICATION.

    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). THE DEVICE IS STILL IN THE INVESTIGATION PROCESS. IF AN INVESTIGATION REPORT AVAILABLE, A FOLLOW-UP REPORT WILL CREATED. 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): "OVERINFUSION" CUSTOMER INFORMATION: DEVICE PUMPS TOO FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116738 PERFUSOR PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1