BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 2632705 · Received June 1, 2012

    Report

    Report Number
    1641965-2012-00011
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    February 6, 2012
    Report Date
    May 7, 2012
    Manufacturer
    B. BRAUN MEDICAL, INC
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: B. BRAUN'S INVESTIGATION HAS FOUND THAT INFUSION PUMP SERIAL# (B)(4) IS PART OF A CORRECTIVE AND PREVENTIVE ACTION (B)(4) INITIATED IN JANUARY 2008 AND IMPLEMENTED IN AUGUST 2008. BACKGROUND: CORRUPTION OF DATA OCCURS DURING PUMP OPERATION UNDER LOW BATTERY CONDITIONS. BECAUSE THE CONFIGURATION DATA IS NOT SAVED, UPON CORRUPTION THE CONFIGURATION (I.E. DRUG LIBRARY), DATA IS ERASED AS A SAFETY MEASURE BECAUSE THE INTEGRITY OF THE DATA COULD NOT BE ASSURED. (B)(4) WAS IMPLEMENTED THROUGH THE RELEASE OF SOFTWARE VERSION 151510 FOR ARM 9 MAIN BOARD. (B)(4) WAS IMPLEMENTED TO INCLUDE ADD'L ENHANCEMENTS FOR SOFTWARE VERSION 151518. DISSEMINATION OF THE CAPA ACTION WAS ACCOMPLISHED VIA RELEASE OF MANAGEMENT PROCESSOR SOFTWARE VERSION 151542. UPON CONTACTING THE REPORTING FACILITY, IT WAS DISCOVERED THAT PUMP SERIAL (B)(4) WAS INITIALLY UPGRADED TO SOFTWARE VERSION 151510 BUT NOT TO THE FOLLOWING SOFTWARE VERSIONS 151518 AND 151542. THUS, MAKING THE PUMP STILL SUSCEPTIBLE TO THE CORRUPTION OF THE CONFIGURATION DATA. THE USER FACILITY HAS BEEN ADVISED OF THE CIRCUMSTANCES SURROUNDING THIS DEVICE AND B. BRAUN MEDICAL HAS ALSO, REQUESTED THAT THE PUMP BE RETURNED FOR A FULL EVAL AND A SOFTWARE UPGRADE. FURTHERMORE, ON (B)(4) 2009 A SIMILAR REQUEST WAS MADE TO THE USER FACILITY TO RETURN THE PUMP TO B. BRAUN MEDICAL FOR A FULL INSPECTION. TO DATE, THE PUMP HAS NOT BEEN RETURNED TO B. BRAUN MEDICAL.

    Description of Event or Problem · 1

    LOSS OF DRUG LIBRARY. COMPLAINT (B)(4): NURSE COULD NOT ACCESS DRUG LIBRARY ON INFUSION PUMP. IT APPEARED THAT NO DRUG LIBRARY WAS AVAILABLE FOR USE. PUMP REMOVED FROM SERVICE AND SENT TO BIOMEDICAL ENGINEERING FOR INSPECTION. BIOMEDICAL ENGINEERING CONFIRMED DRUG LIBRARY WAS DROPPED FROM PUMP'S MEMORY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: ADMINISTER A HEPARIN DRIP VIA INFUSION PUMP'S DRUG LIBRARY. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSE TO DO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other