BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTION BLOCK PUMP

    MDR report key: 3931268 · Received June 26, 2014

    Report

    Report Number
    3006540380-2014-00002
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDICAL FLOW SYSTEMS LTD
    Product Code
    MEB
    PMA / PMN Number
    K072053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE LOT YET NOT REPORTED, WE CAN'T TRACE THE MFG DATE. EVAL METHOD: BASED ON THE RECEIVED INCIDENCE REPORT. THE REGULATING SET INCLUDES A FLOW REGULATOR THAT CONTROLS THE ADMINISTRATION FLOW RATE. HAVING THE CATHETER CONNECTED DIRECTLY TO THE EXIT PORT OF THE RESERVOIRS, TUBING WILL RESULT WITH FREE PRESSURIZED FLOW THROUGH THE CATHETER. BASED ON THE INCIDENCE REPORT, THE INCIDENCE IS RESULTED OF USER (AUTHORIZED MEDICAL TEAM MEMBER) ERROR. THE DIRECTIONS FOR USE ARE CLEAR ON PROPER ASSEMBLY OF THE PAIN PUMP. HAD THE FACILITY FOLLOWED THE DIRECTION OF USE, THIS EVENT WOULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, WE RECEIVED PHONE CALL FROM OUR US DISTRIBUTOR INFORMING A "FREE-FLOW" INCIDENCE RESULTED OF WRONG INSTALLATION OF ONE OF OUR PUMPS HAD OCCURRED, PT PASSED AWAY, FARTHER DETAILED INFO WILL BE SUBMITTED ASAP. ON (B)(6) 2014, WE HAD RECEIVED FROM OUR DISTRIBUTOR FIRST INFO (PARTIAL) RELATED TO THE INCIDENCE: A NURSE IN THE PACU OF THE VA WAS SUPPOSED TO PRIME THE REGULATOR, ATTACH IT TO THE RESERVOIR AND THEN HOOK UP THE PT. THE ENDING RESULT WAS THE NURSE HOOKED TO RESERVOIR DIRECTLY UP TO THE CATHETER. THE PROCEDURE WAS A TOTAL KNEE AND THE CATHETER WAS PLACED IN THE FEMORAL/GROIN AREA FOR A FEMORAL NERVE BLOCK. THE ANESTHESIOLOGIST CONFIRMED THAT THE PUMP WAS MISTAKENLY CONNECTED DIRECTLY TO THE CATHETER. THE ENTIRE RESERVOIR EMPTIED IN THE PT. THE PT EVENTUALLY WENT INTO CARDIAC ARREST AND PASSED AWAY THAT DAY. MEDICAL FACILITY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374885 ACTION BLOCK PUMP PUMP, INFUSION PUMP, ELASTOMERIC MEB MEDICAL FLOW SYSTEMS LTD 419102650 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death