BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR BASIC

    MDR report key: 2170959 · Received June 30, 2011

    Report

    Report Number
    1641965-2010-00086
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    September 29, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    P902409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: THIS INCIDENT WAS IDENTIFIED DURING AN AUDIT OF THE SERVICE NOTIFICATION DATABASE, AND HAS BEEN ADDED TO THE COMPLAINT TRACKING SYSTEM. AS THIS INCIDENT WAS ORIGINALLY PROCESSED THROUGH THE SERVICE DEPARTMENT, THE OPERATIONS LOG IS NOT AVAILABLE FOR REVIEW. B. BRAUN COMPLETED AN EVALUATION OF THIS PUMP PER THE PROCEDURE FOR PUMP RETURNS. DURING THIS EVALUATION, THE REPORTED FAILURE WAS REPRODUCED, AND A PROBLEM WAS FOUND WITH THE REAR CASE OF THE UNIT. THE REAR CASE WAS REPLACED. ROUTINE PREVENTIVE MAINTENANCE WAS PERFORMED ON THE PUMP AND THE PUMP WAS TESTED PER THE ROUTINE REPAIR TESTING REQUIREMENTS. THE PUMP MET ALL FINAL INSPECTION CRITERIA. THIS WAS DETERMINED TO BE AN ISOLATED EVENT. THE FACILITY REPORTED NO PATIENT INJURY RELATED TO THIS COMPLAINT. THE PUMP WAS RETURNED TO THE CUSTOMER IN (B)(6) 2008. SERIAL NUMBER HISTORY HAS SHOWN THAT, AS OF (B)(6) 2011, THIS PUMP HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    THE PUMP WAS NOT INFUSING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSOR BASIC INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK