BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART

    MDR report key: 476394 · Received August 1, 2003

    Report

    Report Number
    476394
    Event Type
    Injury
    Date Received
    August 1, 2003
    Date of Event
    July 14, 2003
    Report Date
    July 31, 2003
    Manufacturer
    CARDIAC ASSIST, INC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE IMPLANTING INITIAL TANDEMHEART PUMP, UNIT MALFUNCTIONED (LEAK IN THE PUMP HEAD) PRIOR TO PROCEDURE COMPLETION. REPLACED WITH A NEW TANDEMHEART.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/20/04: PLEASE NOTE THAT THIS EVENT OCCURRED WITH A DEVICE USED IN A PT ENROLLED IN AN ACTIVE IDE CLINICAL EVALUATION OF THE TENDEMHEART PTVA @ SYSTEM. IN ACCORDANCE WITH 21 CFR 803.19(A)(2), CARDIACASSIST DETERMINED THAT A REPORT WAS NOT REQUIRED FOR THIS EVENT. HOWEVER, MFR HAS COMPLIED WITH REQUEST AND PROVIDED THE SUPPLEMENTAL INFO. THE DEVICE IN QUESTION WAS RETURNED TO CAI FOR EVAL. AN INFUSATE SYSTEM WAS ATTACHED TO THE PUMP AND MFR WAS ABLE TO CONFIRM SEEPAGE OF INFUSATE AT A CONNECTION POINT IN THE PUMP ASSEMBLY. THE DESIGN OF THE TANDEMHEART PVAD SEPARATES THE PUMP INTO TWO FLUID CHAMBERS; THE UPPER HOUSING BLOOD SIDE AND THE LOWER HOUSING INFUSATE SIDE. THE INFUSATE SEEPED THROUGH THE THREADED JOINT BETWEEN THESE TWO HOSUINGS. TWO SEALING METHODS ARE USED TO PREVENT THIS INFUSATE LOSS. THE FIRST SEAL IS AN O-RING BETWEN THW TWO HOUSINGS. THE SECOND SEAL IS AN ADHESIVE APPLIED TO THE THREADED JOINT BETWEEN THE TWO PIECES. THE PATH THROUGH WHICH THE INFUSATE SEEPED DID NOT HAVE ANY APPARENT VISUAL DAMAGE, EVEN UNDER MAGNIFICATION. THE DEVICE WAS THEN DISASSEMBLED, AND MFR COULD NOT IDENTIFY ANY DISCREPANCY WITH THE O-RING. A ROOT CAUSE OF THIS DOUBLE DEAL LOSS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART CARDIAC ASSIST DSQ CARDIAC ASSIST, INC PVAD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention