BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15341089 · Received September 1, 2022

    Report

    Report Number
    9610825-2022-00364
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Report Date
    November 21, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT (B)(6). USE HISTORY: THE DATE OF OCCURRENCE WAS NOT REPORTED. WE VERIFIED IN THE USAGE HISTORY THE VOLUME PROGRAMMING OF 152.6ML WITH A REDUCTION OF 20ML. THE SCHEDULE WAS PERFORMED ON 08/05/2022 AND THE INFUSION TOOK PLACE EXACTLY AS SCHEDULED. NO INFUSION ERRORS WERE RECORDED IN THE HISTORY. HOWEVER, AS THE USER REPORTED HE DID NOT VISUALLY NOTICE THAT THE DRUG WAS INFUSED. WE SIMULATED INFUSION USING A FLOW RATE OF 152.6ML/H FOR A VOLUME OF 132.6ML. PROGRAMMED VOLUME: 132.6 ML - INFUSION VOLUME: 136 ML ERROR: 2.6% RESULT: APPROVED. NOTE 1: GRADUATED GLASS BEAKER USED IN THE TEC-311400 TEST, CERTIFICATE NO. 1426/22. NOTE 2: ADMINISTRATION FEE ACCURACY SET ±5% IN ACCORDANCE WITH IEC/EN60601-2-24. TECHNICAL COMPLAINT NOT CONFIRMED. 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 · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "UNDERINFUSION." CUSTOMER STATEMENT: "PATIENT RECEIVES DOCETAXEL WITH A VOLUME OF 152.6ML B IDENTIFIED IN BAG, IC PROGRAMMING IS PERFORMED, DEDUCTING 20ML FROM THE VOLUME, DUE TO SPIKE. AT THE END OF THE INFUSION PUMP PROGRAMMING, THE FORECAST BAG HAS ITS VOLUME COMPLETED, A NEW PROGRAMMING WAS PERFORMED, APPROXIMATELY 80 ML OF PROGRAMMING. REPROGRAMMED INFUSION PUMP AND DOUBLE CHECKING PERFORMED WITH THE NURSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676529 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown