BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIATURE CENTRIFUGAL PUMP

    MDR report key: 387778 · Received April 10, 2002

    Report

    Report Number
    2954301-2002-00001
    Event Type
    Death
    Date Received
    April 10, 2002
    Date of Event
    March 11, 2002
    Manufacturer
    A-MED SYSTEMS, INC.
    Product Code
    KFM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SOUTHWEST AREA MANAGER, A-MED SYSTEMS, INC., REPORTED THAT A DOCTOR USED THE PUMPS ALONG WITH THE JUGULAR COAXIAL CANNULA AS A RIGHT VENTRICULAR ASSIST SYSTEM IN A PATIENT WITH A LARGE RIGHT VENTRICULAR AND LEFT VENTRICULAR INFERIOR INFARCT. THE PATIENT EXPIRED DUE TO THIS CONDITION AFTER THE FAMILY ELECTED TO TERMINATE TREATMENT. A-MED RECEIVED TWO PUMPS AND ONE JUGULAR COAXIAL CANNULA ON MARCH 13, 2002. FROM THE NOTATION ON THE SHIPPER BOX, IT WAS DECIPHERED THAT ONE PUMP WAS USED FOR SIX HOURS AND REPLACED WITH ANOTHER PUMP WHICH WAS USED FOR 10 HOURS AND 45 MINUTES. USE OF PUMP FOR LONGER THAN SIX HOURS IS AGAINST THE INDICATION. THE JUGULAR COAXIAL CANNULA IA A PROTOTYPE UNAPPROVED DEVICE. A-MED NEITHER AUTHORIZED CLINICAL USE OF THE JUGULAR COAXIAL CANNULA NOR HAD PRIOR KNOWLEDGE OF THE INTENTION TO USE THE DEVICE CLINICALLY. PATIENT'S DEATH WAS NOT RELATED TO DEVICE USE PER DOCTOR'S ADMISSION. DOCTOR PROVIDED A COPY OF THE EMERGENCY USE REPORT AND A LETTER INDICATING THAT DEVICE DID NOT CONTRIBUTE IN ANY WAS TO PATIENT DEATH. RETURNED PRODUCT WAS INVESTIGATED. INVESTIGATION REVEALED THAT THE DEVICES WERE FUNCTIONAL. THIS IS CORROBORATED BY THE INFORMATION OBTAINED FROM THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIATURE CENTRIFUGAL PUMP NON-ROLLER TYPE CARDIOPULMONARY BYPASS BLOOD PUMP KFM A-MED SYSTEMS, INC. CP-1 05-092501-01

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death