BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 2170977 · Received June 30, 2011

    Report

    Report Number
    1641965-2011-00040
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: THE PUMP'S OPERATION LOG WAS DOWNLOADED AND REVIEWED. THERE WERE 10 INFUSIONS ON THE DATE REPORTED, INCLUDING 3 IN PRIMARY MODE AND 7 IN PIGGYBACK MODE. THERE WERE MULTIPLE HOLDS BETWEEN THE INFUSIONS. ONLY ONE PIGGYBACK INFUSION WAS ALLOWED TO SWITCH TO PRIMARY MODE, WHICH IT DID WITH NO ISSUES. ALL INFUSIONS MET SPECIFICATIONS BASED ON THE PROGRAMMING OF THE PUMP. THE LAST ENTRY FOR THE DATE OF THE EVENT WAS A SYSTEM ERROR 43, WHICH IS A DOOR OPEN ALARM. THE ONLY SE 122 FOUND IN THE LOG OCCURRED ON (B)(6) 2010. B. BRAUN COMPLETED AN EVALUATION OF THIS PUMP PER THE PROCEDURE FOR COMPLAINT RETURNS. AS PART OF THE ROUTINE COMPLAINT TESTING REQUIREMENTS, THE RETURNED PUMP WAS TESTED FOR VOLUMETRIC ACCURACY FIVE TIMES WITH 5 ML VOLUME TO BE DELIVERED (SPECS: 4.75 - 5.25 ML). THREE TESTS AT 999 ML/HR HAD PASSING RESULTS OF 5.01 ML, 5.06 ML AND 5.00 ML, AND TWO TESTS AT 38 ML/HR HAD PASSING RESULTS OF 4.79ML AND 4.93 ML. THE PUMP MET ALL COMPLAINT TESTING REQUIREMENTS, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE PUMP WAS RETURNED TO THE FACILITY ON (B)(6), 2011 AND AS OF (B)(6) 2011, HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    PUMP FAILED TO STOP. ON (B)(6) 2010, AN INCIDENT OCCURRED WHERE THE PUMP FAILED TO BEEP OR STOP, WHICH CAUSED AN IV INFILTRATION. THE PUMP SHOWED SYSTEM ERROR 122. THE FACILITY WILL NOT RELEASE ANY FURTHER INFORMATION CONCERNING THE INCIDENT OR THE STATUS OF THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK