BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA 70CC TAH-T

    MDR report key: 5836846 · Received August 1, 2016

    Report

    Report Number
    3003761017-2016-00266
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 12, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE TAH-T WAS STILL IMPLANTED IN THE PATIENT AT THE TIME OF THE COMPLAINT. SYNCARDIA REQUESTED THAT THE TAH-T AND CANNULAE BE RETURNED TO SYNCARDIA FOR EVALUATION AFTER THE PATIENT WAS TRANSPLANTED. AN EXPLANT EVALUATION WAS COMPLETED ON TAH-T L/N 090260 WHEN RETURNED TO SYNCARDIA AFTER THE PATIENT WAS TRANSPLANTED, HOWEVER, THE EXPLANTED TAH-T DID NOT CONTAIN THE CANNULAE OR CANNULA VELOUR. THEREFORE, AN EVALUATION OF THE REPAIRED CANNULAE SECTION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW DETERMINED 70CC TAH-T, LOT# 090260 MET ALL SPECIFIED REQUIREMENTS PRIOR TO SHIPMENT. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THE FILE. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN SUPPORTED BY THE TAH-T SYSTEM FOR 341 DAYS AT THE TIME OF THE REPORTED ISSUE. THE CUSTOMER REPORTED THAT THE VELOUR COVERINGS ON THE 70CC TAH-T CANNULAE WERE "MOVING/ROTATING ON THE CANNULAE". THE CUSTOMER ALSO REPORTED THAT THE 70CC TAH-T CANNULAE WERE SUCCESSFULLY REPAIRED BY THE HOSPITAL STAFF BY APPLYING SILICONE TAPE AT THE DISTAL EDGE OF THE VELOUR/CANNULA INTERSECTION TO ENSURE NO ROTATION OF THE VELOUR ON CANNULAE WAS ABLE TO OCCUR. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT AS A RESULT OF THE VELOUR ROTATION ON THE CANNULAE AND SUBSEQUENT REPAIR. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THERE WAS A ROTATION OF THE VELOUR ON THE TAH-T CANNULAE, THE TAH-T SYSTEM CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE TAH-T IS STILL IMPLANTED IN THE PATIENT. SYNCARDIA HAS REQUESTED THAT THE TAH-T AND CANNULAE BE RETURNED TO SYNCARDIA FOR EVALUATION AFTER THE PATIENT HAS BEEN TRANSPLANTED. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN SUPPORTED BY THE TAH-T SYSTEM FOR 341 DAYS AT THE TIME OF THE REPORTED ISSUE. THE CUSTOMER REPORTED THAT THE VELOUR COVERINGS ON THE 70CC TAH-T CANNULAE WERE "MOVING/ROTATING ON THE CANNULAE". THE CUSTOMER ALSO REPORTED THAT THE 70CC TAH-T CANNULAE WERE SUCCESSFULLY REPAIRED BY THE HOSPITAL STAFF BY APPLYING SILICONE TAPE AT THE DISTAL EDGE OF THE VELOUR/CANNULA INTERSECTION TO ENSURE NO ROTATION OF THE VELOUR ON CANNULAE WAS ABLE TO OCCUR. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT AS A RESULT OF THE VELOUR ROTATION ON THE CANNULAE AND SUBSEQUENT REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491157 SYNCARDIA 70CC TAH-T BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 090260

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR