BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9519493 · Received December 26, 2019

    Report

    Report Number
    2916596-2019-05767
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    December 4, 2019
    Report Date
    April 13, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT WAS CONFIRMED. THE HM3 SEALED OUTFLOW GRAFT WAS RETURNED IN LIKE-NEW CONDITION. VISUAL INSPECTION OF THE GRAFT CONFIRMED THAT THE LOCKING NUT WAS NOT FULLY THREADED DOWN, RESULTING IN THERE BEING NO GAP FOR THE DISTAL SIDE OF THE OUTFLOW GRAFT CLIP TO SLIDE INTO. THE GRAFT HARDWARE WAS DISASSEMBLED TO FURTHER VISUALIZE THE ISSUE AND THE LOCKING NUT WAS FOUND TO BE FULLY MOBILE IN BOTH THE TIGHTEN AND LOOSEN DIRECTIONS. THE THREADS ON THE HARDWARE DID NOT SHOW DAMAGE OR DEFECTS THAT WOULD HAVE PREVENTED THE LOCKING NUT FROM BEING TORQUED DOWN AND THE NUT COULD BE EASILY ROTATED INTO THE FULLY THREADED POSITION. INSPECTION OF THE PART UNDER A MICROSCOPE FOUND THE METAL TO BE SMOOTH WITH NO VISIBLE TOOL MARKS FROM A TORQUE WRENCH. THE ISSUE WAS FURTHER INVESTIGATED BY MANUFACTURING AND THE PROBABLE ROOT CAUSE WAS IDENTIFIED. SEVERAL PROCESS IMPROVEMENTS HAVE BEEN IMPLEMENTED AND ADDITIONAL IMPROVEMENTS ARE CURRENTLY IN PROCESS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HEARTMATE 3 PUMP PREPARATION ASSEMBLY, THE PERFUSIONIST ATTEMPTED TO INSTALL THE OUTFLOW GRAFT (OFG) CLIP PER STANDARD PROCEDURE. HOWEVER, THE CLIP WOULD NOT ENGAGE IN THE GROOVE BETWEEN THE OFG COLLAR. THE PERFUSIONIST VISUALLY COMPARED THE DEMO OFG AND NOTED THERE WAS NO SPACING TO INSERT THE OFG CLIP. THE SITE SWAPPED THE OFG CLIP WITHOUT INCIDENT. THERE WERE NO REPORTED ADVERSE EVENTS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316005 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization