BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 2932432 · Received January 8, 2013

    Report

    Report Number
    9610825-2012-00289
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT #(B)(4). THE INVESTIGATION ON THE DEVICE IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT #(B)(4). RESULT OF EXAMINATION: THE HISTORY FILES WERE READ AND ANALYZED. AFTER A PRESSURE ALARM WAS CONFIRMED THE DESCRIBED DEVICE ALARM 1018 OCCURRED. AFTER RESTART IT ALERTED AGAIN. THE DEVICE WAS ACTUATED ONCE AGAIN A FEW DAYS LATER. THE DEVICE SHOWED SLIGHTLY EXTERNAL DAMAGES. THE DRIVE HEAD SHOWED A NOTICEABLE CLEARANCE IN VERTICAL DIRECTION. IN ADDITION, THE INSIDE OF THE DEVICE WAS INVESTIGATED. MATERIAL COMPRESSIONS AT THE BOTTOM AS WELL AS OF THE UPPER HOUSING WERE FOUND. THE DEVICE HAS BEEN THE OBJECT OF A MASSIVE EXTERNAL IMPACT. ACCORDING TO THE HISTORY FILES THIS IMPACT HAD TO BE HAPPENED BEFORE THE DATE OF EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE ANY PUMP HAS TO BE VISIBLY INSPECTED PRIOR TO ADMINISTRATION. IF THE DEVICE FALLS OR IS EXPOSED TO FORCE IT NEEDS TO BE EXAMINED BY THE SERVICE DEPT. THE SOFTWARE VERSION IS NOT DISTRIBUTED IN THE US. THE SECOND INVOLVED PUMP IS REPORTED UNDER MFR REPORT I# 9610825-2012-00290.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN THE NETHERLANDS): DEVICE ALARM DURING TRANSPORT SITUATION: DURING TRANSPORT OF THE PATIENT FROM THE OKC TO THE ICU THEY HAD TWO PUMPS WITH NOREPINEFRINE 0,2MG/ML. ONE PUMP WITH FLOW 8,3ML/HR, THE OTHER WITH FLOW 0,LML/HR. WHEN THEY CHANGED THE FLOW OF THE FIRST PUMP, AND CONFIRMED THIS CHANGE, THE PUMP WENT INTO DEVICE ALARM :1132. AFTER THAT THEY WANTED TO USE THE SECOND PUMP WITH , FLOW 0,1 ML/HR, BUT IT WENT INTO A USER ALARM. WHEN THIS ALARM WAS CONFIRMED WITH OK IT WENT INTO DEVICE ALARM 1018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68088 PERFUSOR SPACE INFUSION SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| D