BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16461650 · Received March 1, 2023

    Report

    Report Number
    2916596-2023-01230
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 22, 2023
    Report Date
    May 30, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THERE WAS INTERFERENCE BETWEEN THE PATIENT'S HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND A STRYKER DEFIBRILLATOR, MODEL LP 15. WHEN THE PATIENT WAS CONNECTED TO THE EXTERNAL DEFIBRILLATOR USING DIRECT SKIN LEADS, ARTIFACT WAS PRODUCED THAT INTERFERED WITH CARDIOVERSION TREATMENT. THE DIRECT SKIN LEADS WERE REPLACED BY AN ELECTROCARDIOGRAM (ECG) SLAVE CABLE AND CARDIOVERSION WAS SUCCESSFULLY PERFORMED. THERE WERE NO ALARMS OR PATIENT IMPACT REPORTED FOR THE EVENT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION C, "SAFETY TESTING AND CLASSIFICATION" STATES: THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM HAS BEEN TESTED AND FOUND TO COMPLY WITH THE LIMITS FOR MEDICAL DEVICES TO THE IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY. THESE LIMITS ARE DESIGNED TO PROVIDE REASONABLE PROTECTION AGAINST HARMFUL INTERFERENCE IN A TYPICAL MEDICAL INSTALLATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM CAN GENERATE, USE, AND RADIATE RADIO FREQUENCY ENERGY AND, IF NOT INSTALLED AND USED IN ACCORDANCE WITH THE INSTRUCTIONS, MAY CAUSE HARMFUL INTERFERENCE TO OTHER DEVICES IN THE VICINITY. HOWEVER, THERE IS NO GUARANTEE THAT INTERFERENCE WILL NOT OCCUR IN A PARTICULAR INSTALLATION. IF THIS EQUIPMENT DOES CAUSE HARMFUL INTERFERENCE TO OTHER DEVICES, THE USER IS ENCOURAGED TO TRY TO CORRECT THE INTERFERENCE BY ONE OR MORE OF THE FOLLOWING MEASURES: ¿ REORIENT OR RELOCATE THE EQUIPMENT. ¿ INCREASE THE SEPARATION BETWEEN THE EQUIPMENT. ¿ CONNECT THE EQUIPMENT INTO AN OUTLET ON A CIRCUIT DIFFERENT FROM THAT TO WHICH THE OTHER DEVICE(S) ARE CONNECTED. ¿ CONSULT THE MANUFACTURER FOR ASSISTANCE. THE IFU ALSO NOTES THAT SPECIAL PRECAUTIONS ARE REQUIRED FOR INSTALLING AND USING THE HEARTMATE 3 LVAS WITHIN PORTABLE AND RADIO FREQUENCY COMMUNICATION ENVIRONMENTS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-033306 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT WAS CONNECTED TO A DEFIBRILLATOR USING DIRECT SKIN LEADS, EXCESSIVE ARTIFACT WAS PRODUCT WHICH MADE SYNCH CARDIOVERSION A PROBLEM. THE DIRECT SKIN LEADS WERE SWITCHED WITH AN ECG SLAVE CABLE MOVING THE ECG FROM BEDSIDE MONITOR TO THE DEFIBRILLATOR AND THE ISSUE RESOLVED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921429 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 8581302 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male