BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 15786208 · Received November 13, 2022

    Report

    Report Number
    9610825-2022-00471
    Event Type
    Malfunction
    Date Received
    November 13, 2022
    Report Date
    November 8, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). 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. THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO DATE OF THE INCIDENT WAS GIVEN AND DUE TO THE VERY IMPRECISE ERROR DESCRIPTION OF THE CUSTOMER, NO PRECISE ANALYSIS OF THE DEVICE HISTORY CAN BE DONE. NO ABNORMALITIES CAN BE FOUND IN THE DEVICE HISTORY FILES. A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE WAS IN A NORMAL CONDITION AND NO VISIBLE DAMAGE ARE TO LOCATED. A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF TEST. A OPS 50ML SYRINGE WAS INSERTED, AND THE PUMP IDENTIFIED THE SYRINGE AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 5 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF +0,34%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED. TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FINLAND: "OVERINFUSION" "THE NURSE DID NOT KNOW HOW TO USE THE SYRINGE PUMP, WHICH HAS A DIFFERENT HOLDER THAN THE ONES WHERE ONLY 50ML PERFUSOR SYRINGES GO. SO NOW THERE IS A TOTAL OF 40ML OF LIQUID IN THE SYRINGE. THE SYRINGE DIDN'T FIT IN PLACE / THE DEVICE DETECTED THE WRONG SYRINGE, SO I TRIED TO PUT IT IN THE HOLDER IN A DIFFERENT WAY BY MOVING THE SYRINGE. HOWEVER, I HAD PUT THE TUBE INTO THE PATIENT VIA A THREE-WAY VALVE. WHILE MOVING/HANDLING/TRYING TO PUT THE SYRINGE IN ITS PLACE, I NOTICED THAT THERE IS ONLY 20ML OF LIQUID IN THE SYRINGE, ALTHOUGH IT SHOULD HAVE BEEN THE 40ML I JUST DILUTED. I CLOSED THE THREE WAY TAP AND CALLED FOR HELP. A COLLEAGUE CAME TO HELP. I CALLED THE DOCTOR ON DUTY AND TOLD HIM WHAT HAD HAPPENED. SO THE PATIENT WAS SUPPOSED TO GET INFUSED OXANEST 2ML/H INTO THE SYRINGE PUMP AND NOW HE GOT 20MG IN A QUICK TIME. IN ADDITION, THE PATIENT'S BREATHING WAS MORE GASPING AFTER RECEIVING THE MEDICINE. THE BREATHING FREQUENCY DID NOT SLOW DOWN IN THE MEANTIME, BUT LATER WHEN SHE RECEIVED NALOXONE A SECOND TIME, THE RESPONSE WAS CLEARER. ACTIONS CAUSED BY THE EVENT: THE PATIENT RECEIVED A SIGNIFICANT AMOUNT OF THE DRUG, A DOCTOR WAS CALLED TO THE SCENE AND THE EFFECT WAS REVERSED WITH NALOXONE. THE PATIENT DEMANDED CLOSER FOLLOW-UP DUE TO THE INCIDENT. NO PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830561 PERFUSOR SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown