BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 9618085 · Received January 22, 2020

    Report

    Report Number
    9610825-2020-00006
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 19, 2019
    Report Date
    February 21, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. VOLUMETRIC'S AND AIR SENSOR CHECKS WERE PERFORMED AND TESTED IN SPECIFICATION. WHEN AN AIR BUBBLE OF 0.4 ML WAS INTRODUCED THE PUMP ALARMED AS INTENDED. THE AIR SENSOR WAS TESTED FOR AIR IN TUBING AND FLUID IN TUBING, AND BOTH TESTS WERE WITHIN SPECIFICATION. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. 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. ADDITIONAL ATTEMPTS TO RECEIVE THE DEVICE INVOLVED IN THE REPORTED EVENT ARE BEING MADE. 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: AIR IN THE TUBING FROM THE PUMP TOWARDS THE PATIENT. THE AIR DID NOT REACH THE PATIENT. THE NURSE STATED THAT SHE DID NOT GET ANY AIR IN LINE ALARMS FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80620 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1