BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 11063713 · Received December 23, 2020

    Report

    Report Number
    2531527-2020-00037
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 22, 2020
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    KFM
    PMA / PMN Number
    K110493
    Removal / Correction Number
    Z-1948-2020/Z-1955-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ROOT CAUSE OF THE FAILURE TO PRIME WAS THE BAFFLE SEAL DEFORMATION, LIKELY CAUSED BY THE ASSEMBLER NOT CONFIRMING ROTATION DURING ANALYSIS.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. CARDIAC ASSIST. INC. MANUFACTURES THE TANDEM HEART PUMP. THE INCIDENT OCCURRED IN (B)(6). THE PUMP INVOLVED IN THE REPORTED EVENT IS PART OF VOLUNTARY MEDICAL DEVICE REMOVAL INITIATED BY LIVANOVA ON (B)(6) 2020 AND ALREADY TERMINATED. THE Z NUMBER IS (B)(4). LIVANOVA RECEIVED THE CUSTOMER RESPONSE FORM STATING THAT THE INVENTORY HAD BEEN INSPECTED AND THAT THE PUMP COULD NOT BE LOCATED. LIVANOVA PERFORMED ATTEMPTS TO CLARIFY IF THE PUMP HAD BEEN USED OR DISCARDED AND THE INFORMATION THAT THE PUMP WAS NOT IN THE INVENTORY WAS RECEIVED. THEREFORE, LIVANOVA BELIEVES ADEQUATE EFFORT HAS BEEN DONE TO REMOVE ALL POTENTIALLY AFFECTED UNITS AND THAT THE CAUSE OF THE DEVICE NOT BEING REMOVED WAS A HUMAN INVENTORY INSPECTION ERROR DONE BY THE CUSTOMER. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED REPORT ABOUT A TANDEMHEART PUMP WHICH FAILED TO BE PRIMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528162 TANDEMHEART PUMP NON-ROLLER TYPE BLOOD PUMP KFM CARDIACASSIST INC. 5120-0000

    Patients

    Seq Age Sex Outcome Treatment
    1