BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 8883690 · Received August 12, 2019

    Report

    Report Number
    9610825-2019-00351
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Report Date
    November 14, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN MELSUNGEN, GERMANY. DURING THE ANALYZES OF THE HISTORY LOG FILES NO FLOW DEVIATION COULD BE DETECTED. DURING THE VISIBILE INVESTIGATION IT COULD BE DETECTED SOME AGE RELATED SIGNS OF WEAR AND TEAR. AS PART OF THE FUNCTIONAL CHECK THE SELF TEST OF THE INFUSOMAT SPACE COULD BE SUCCESSFULLY PERFORMED. AN INFUSOMAT SPACE LINE COULD BE INSERTED AND WAS RECOGNIZED BY THE PUMP. AFTER THE LINE SELECTION THE DELIVERY MODE COULD BE STARTED WITHOUT ANY RESERVATIONS. AFTER THE FUNCTIONAL TEST A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. FOR THIS THE DELIVERY ACCURACY MEASUREMENT THE PRESSURE CUT-OFF AND THE PRESSURE LIMITATION WERE CHECKED. FURTHERMORE THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. THE DEVICE FULFILLS THE REQUIRED VALUES ACCORDING TO THE SPECIFICATIONS OF THE TECHNICAL SAFETY CHECK (TSC). DURING AN INSIDE INVESTIGATION IT COULD BE DETECTED A LOT OF RESIDUES OF LIQUID. THE COMPLAINT COULD NOT BE CONFIRMED. DURING A FLOW MEASUREMENT NO FLOW DEVIATION COULD BE DETECTED. THE DEVICE WORKS WITHIN OUR SPECIFICATION. BUT THROUGH THE INSIDE INVESTIGATION, IT SEEMS LIKE THAT THE DEVICE WAS NOT CORRECTLY HANDLED BY USER.

    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)(6). IF WE GET NEW INFORMATION ABOUT THIS COMPLAINT, A FOLLOW UP REPORT WILL BE CREATED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY BY BBM SALES ORGANIZATION IN UNITED (B)(6): CUSTOMER INFORMATION: RATE WAS SET UP TO RUN FOR 24 HOURS, THE PUMP ONLY RAN FOR 9 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678681 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1