BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 680229 · Received February 23, 2006

    Report

    Report Number
    9616026-2006-00020
    Event Type
    Malfunction
    Date Received
    February 23, 2006
    Date of Event
    August 4, 2005
    Report Date
    August 8, 2005
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING THE SELF TEST FOLLOWING THE CHANGING OF SOLUTIONS ON BAGS AND HITTING THE "CHANGE BAG" SOFTKEY, THE PHYSICIAN NOTICED AN UNUSAL NOISE, WHICH WAS DESCRIBED AS SIMILAR TO THE SOUND MADE DURING "UNLOAD SET" BY THE PRISMA CFM MACHINE. THE PHYSICIAN NOTICE THE BLOOD PUMP STOPPED WHILE THE OTHER PUMPS INCLUDING THE PBP. PUMP WERE ACTIVE. NO ALARM WAS TRIGGERED. THE PHYSICIAN NOTICED THE ACCESS BLOOD LINE WAS COMPLETELY FILLED WITH PBP SOLUTION, INDICATING THAT THE PBP PUMPED THE SOLUTION VIA THE ACCESS LINE AND THE CATHETER BACKWARDS INTO THE PATIENT. THE ACCESS BLOOD LINE WAS IMMEDIATELY CLAMPED AND THE TREATMENT STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS KDI GAMBRO LUNDIA AB 107493 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other