BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 6861212 · Received September 13, 2017

    Report

    Report Number
    9610825-2017-00182
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Report Date
    August 28, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964708626
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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). 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 · 0

    AS REPORTED BY USER FACILITY: FREE FLOW ISSUE. LIMITED INFORMATION PROVIDED, INCLUDING WHETHER OR NOT THE PUMP WAS HOOKED UP TO A PATIENT AT THE TIME. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). 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) DELIVERY ACCURACY TESTS OF 250ML/HR AND 25ML WERE PERFORMED WITH THE DOOR BOTH OPENED AND CLOSED AND ALL THREE (3) TESTED IN SPEC WITH NO FREE FLOW OBSERVED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642358 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 04046964708626

    Patients

    Seq Age Sex Outcome Treatment
    1