BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2771718 · Received September 10, 2012

    Report

    Report Number
    3003761017-2012-00060
    Event Type
    Other
    Date Received
    September 10, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 7, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNCARDIA REQUESTED THAT THE TAH-T AND CANNULAE BE RETURNED TO SYNCARDIA FOR EVALUATION AFTER THE PT IS TRANSPLANTED. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR. SYNCARDIA INITIATED A CAPA (CORRECTIVE OR PREVENTIVE ACTION) TO ADDRESS THE CANNULA TEAR ISSUE. THE CAPA WILL DOCUMENT THE INVESTIGATION INCLUDING, BUT NOT LIMITED TO, POTENTIAL ROOT CAUSE AND CORRECTIVE ACTIONS ASSOCIATED WITH ALL CANULA TEAR EVENTS. FROM 2004 TO (B)(4) 2012, THERE HAVE BEEN A TOTAL OF (B)(4) TAH-T IMPLANTS WORLDWIDE AND A TOTAL OF (B)(4) TAH-T PTS WHO EXPERIENCED A CANNULA BREACH, FOR A RATE OF ABOUT (B)(4) PERCENT ((B)(4)). NONE OF THE PTS EXPERIENCED ANY INJURIES AS A RESULT OF THE CANNULA TEARS. THEREFORE, THE RISK ASSOCIATED WITH THIS ISSUE IS LOW FOR OCCURRENCE AND LOW FOR SEVERITY.

    Description of Event or Problem · 1

    (B)(4) WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AT (B)(6) CENTER IN (B)(6) ON (B)(6) 2012. THE CUSTOMER REPORTED THE FOLLOWING: ON (B)(6) 2012, AFTER 182 IMPLANT DAYS, (B)(4) REPORTED THAT HE FOUND SOME "CUTS" ON THE OUTSIDE OF HIS RIGHT TAH-T CANNULA. THE PT AND THE CLINICIANS AT (B)(6) CENTER THINK THAT THE CUTS MIGHT HAVE BEEN CAUSED BY WEARING A BELT ON HIS PANTS. WHEN THE PT WAS AT THE CLINIC, IT WAS FOUND THAT THE RIGHT CANNULA ALSO HAD AN AIR LEAK. THE RIGHT CANNULA WAS REPAIRED AND THE AIR LEAK WAS RESOLVED BY WRAPPING THE CANNULA WITH VULCANIZING TAPE. THERE WAS NO IMPACT TO THE PT. THE PT HAS BEEN ADMITTED TO THE REHABILITATION CENTER AND HE HAS BEEN LISTED AS "HIGH URGENT" FOR TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 075180

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention