BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOCARDIAL PROTECTION SYSTEM CONSOLE

    MDR report key: 308261 · Received December 8, 2000

    Report

    Report Number
    1649914-2000-00002
    Event Type
    Death
    Date Received
    December 8, 2000
    Date of Event
    November 8, 2000
    Report Date
    December 6, 2000
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER A SUCCESSFUL PRIME, THE MPS WAS SET UP FOR USE ON A CRITICALLY ILL PT WHO WAS BEING OPERATED ON TO CORRECT A DISSECTED AORTIC ANEURYSM. WITHIN THE TUBING CIRCUIT SUPPLYING BLOOD TO THE MPS, A HEMOCONCENTRATOR WAS INSTALLED. THE RESISTANCE THROUGH THE HEMOCONCENTRATOR WAS EXCESSIVE AND CREATED ABNORMAL EXCESSIVE PRESSURE WITHIN THE BLOOD LINE SUPPLYING THE MPS, CAUSING THE MPS TO DISPLAY AN "OVER MAX PRESSURE" ERROR WHEN THE FLOW WAS ATTEMPTED TO BE DELIVERED. THIS CAUSED THE MPS TO DISCONTINUE FLOW. IT WAS DETERMINED THAT A HIGH INPUT PRESSURE CONDITION EXISTED. THE PERFUSIONIST RESOLVED THE INPUT OVER PRESSURE CONDITION, POWER CYCLED THE UNIT, AT WHICH TIME THE MPS RESUMED FLOW AND FUNCTIONED NORMALLY. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE MPS PERFORMED WITHIN SPECIFICATION DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOCARDIAL PROTECTION SYSTEM CONSOLE * DTR QUEST MEDICAL, INC. 5001000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death