BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEMHEART PUMP

    MDR report key: 8506094 · Received April 11, 2019

    Report

    Report Number
    2531527-2019-00032
    Event Type
    Death
    Date Received
    April 11, 2019
    Date of Event
    March 14, 2019
    Report Date
    June 7, 2019
    Manufacturer
    CARDIAC ASSIST INC.
    Product Code
    KFM
    PMA / PMN Number
    K110493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT TYPE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CONTAIN INFORMATION ABOUT PATIENT DEATH. OUTCOMES ATTRIBUTED TO ADVERSE EVENT (CHECK ALL THAT APPLY), CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CONTAIN INFORMATION ABOUT PATIENT DEATH. DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CONTAIN INFORMATION ABOUT PATIENT DEATH. TYPE OF REPORTABLE EVENT, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CONTAIN INFORMATION ABOUT PATIENT DEATH. H6 EVENT PROBLEM AND EVALUATION CODES, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CONTAIN INFORMATION ABOUT PATIENT DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPIRED DURING THE CASE.

    Description of Event or Problem · 0

    THE PUMP WAS RETURNED AND ANALYSIS WAS COMPLETED. DURING PRODUCT ANALYSIS, IT WAS FOUND THE PUMP PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS DURING THE SIMULATION. THERE WERE PARTICULATES FOUND IN THE JOURNAL BORES AND SCORING MARKS PRESENT IN THE LOWER HOUSING. BASED ON THIS INFORMATION, THE CAUSE OF THE PUMP ISSUES WAS CAUSED BY AN UNPRIMED LOWER HOUSING OF THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ATTEMPTED TO BE PLACED ON TANDEMHEART HOWEVER WHEN THE PUMP WAS CONNECTED TO THE CIRCUIT, IT STOPPED WORKING. THE CONTROLLER WENT INTO BACKUP MODE INDICATING THE PUMP COULD NOT START. THE DECISION WAS MADE TO PUT THE PATIENT ON A DIFFERENT SYSTEM AT THAT TIME. TROUBLESHOOTING WAS PERFORMED TO ATTEMPT TO GET THE PUMP TO FUNCTION HOWEVER IT DID NOT WORK. THE PUMP WAS STATED TO BE AVAILABLE FOR RETURN HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299057 TANDEMHEART PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM CARDIAC ASSIST INC. 5120-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death