BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 8612864 · Received May 15, 2019

    Report

    Report Number
    9610825-2019-00181
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 14, 2019
    Report Date
    May 15, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN (B)(6). DURING THE ANALYSIS OF THE HISTORY FILES ONE AIR BUBBLE ALARM COULD BE DETECTED. THE SAMPLE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. A BROKEN HOLDER FOR THE OPERATING UNIT COULD BE DETECTED. A FUNCTIONAL TEST WAS PERFORMED. THE SELF TEST WAS SUCCESSFULLY FINISHED AND IT WAS POSSIBLE TO BRING THE PUMP IN OPERATION. A DELIVERY ACCURACY MEASUREMENT ACCORDING WAS ARRANGED. THE DOWNSTREAM SENSOR WAS CHECKED AND THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. FURTHER A SPECIAL FUNCTIONAL TEST OF THE AIR SENSOR WAS PERFORMED. AIR BUBBLES WERE INJECTED INTO THE INFUSION LINE AND WERE RECOGNIZED BY THE AIR SENSOR. ALL VALUES ACCORDING TO THE SPECIFICATIONS OF THE TECHNICAL SAFETY CHECK (TSC). DURING THE DISASSEMBLING THE DEVICE ONLY THE BROKEN HOLDER FOR THE OPERATING UNIT COULD BE FOUND. THE COMPLAINT COULD BE NOT CONFIRMED. DURING THE PERFORMED DELIVERY ACCURACY MEASUREMENT AND THE TEST OF THE AIR SENSOR NO DEVIATION OF THE PUMP COULD BE DETECTED. THE PUMP OPERATE WITHIN OUR SPECIFICATION. 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 (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): "THE PUMP/TUBING HAS LET THE AIR PASS". NO MORE FURTHER CUSTOMER INFORMATION WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406753 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1