BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 6579306 · Received May 19, 2017

    Report

    Report Number
    9610825-2017-00087
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Report Date
    April 21, 2017
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). 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 250ML/HR AND 25ML TESTED IN SPEC WITH NO FREE FLOW DOOR CLOSED OR OPENED. DURING THE EVALUATION OF THE PUMP, IT WAS DISCOVERED THAT THE PUMP HAD NO CONNECTION TO HIBASED, AND THE MOTHERBOARD WAS REPLACED. THIS ISSUE WOULD NOT HAVE RESULTED IN FREE FLOW, IT WOULD ONLY AFFECT THE PUMP'S ABILITY TO CONNECT TO THE FACILITY'S DRUG LIBRARY WIRELESSLY. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. 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.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: FREE FLOW OF MAGNESIUM. PUMP DID NOT ALARM, THE ISSUE WAS SEEN BY A NURSE. NO PATIENT INJURY. THE INFUSION WAS STOPPED, AND RESTARTED ON ANOTHER PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359858 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1