BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 9597815 · Received January 16, 2020

    Report

    Report Number
    9610825-2019-00562
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    February 27, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. THREE (3) VOLUMETRICS OF 250 ML/HR AND 25 ML WERE PERFORMED AND TESTED IN SPEC. THE REPORTED FAILURE COULD NOT BE REPRODUCED. HOWEVER, DURING THE EVALUATION OF THE PUMP IT WAS OBSERVED THAT THE DOOR WAS DIFFICULT TO CLOSE. THE DOOR BOLT AND THE DOOR DRIVE WERE REPLACED IN ORDER TO RESOLVE THIS ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: DELIVERY ACCURACY HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60596 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713050U 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1