BEUDAMED
    FDA Adverse Event Other Summary report: N

    B. BRAUN PERIFIX KIT CE=18HK

    MDR report key: 550524 · Received July 26, 2004

    Report

    Report Number
    MW1032823
    Event Type
    Other
    Date Received
    July 26, 2004
    Date of Event
    July 25, 2004
    Report Date
    July 26, 2004
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EPIDURAL PUMP SOUNDED "OCCLUSION" ALARM. IT HAD BEEN RUNNING FINE FOR SOME TIME UNTIL THE PT WAS REPOSITIONED, SO CATHETER OCCLUSION WAS SUSPECTED WHEN INJECTION PROVED DIFFICULT. THE CATHETER WAS INSPECTED AND NO KINKING WAS NOTED AND THE PT WAS BECOMING MORE UNCOMFORTABLE, SO THE EPIDURAL CATHETER WAS REPLACED. THE PUMP TUBING HAD BEEN REPLACED AS PART OF THE TROUBLESHOOTING PROCESS. WHEN THE PUMP WAS CONNECTED TO THE NEW FILTER/CATHETER ASSEMBLY, IT TOO ALARMED "OCCLUSION." LATER IT WAS FOUND THAT BOTH FILTERS WERE OCCLUDED OR "AIR LOCKED" -1- DESPITE HAVING BEEN THOROUGHLY PRIMED WITH SALINE PRIOR TO USE. THE PUMP TUBING AND INFUSATE CONTAINER HAD BEEN PURGED OF AIR PRIOR TO USE. THE AIR-EXCLUDING FILTER ON THE INFUSION SET WAS IN USE. -1- LIN, CC. AIR-LOCKED EPIDURAL FILTER ANESTHESIOLOGY: VOLUME 99-2- AUGUST 2003 P 515.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B. BRAUN PERIFIX KIT CE=18HK 0.2 MICRON FILTER COMPONENT OF ABOVE KIT FPB B. BRAUN MEDICAL INC. CE 18 HK 60401354

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other 0.2 MICRON FILTER.| ABBOTT LATEX FREE PUMP SET WITH AIR-ELIMINATING