BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8053243 · Received November 8, 2018

    Report

    Report Number
    2916596-2018-04729
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 20, 2018
    Report Date
    December 10, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE REPORT OF A LOW SPEED AND PUMP STOPPAGE EVENTS WAS CONFIRMED BASED ON THE EVALUATION OF SUBMITTED LOG FILES. THE LOG FILE CONTAINED APPROXIMATELY 21 DAYS OF DATA, SPANNING FROM (B)(6) 2108 18:01 TO (B)(6) 2018 08:53, WHICH CAPTURED NUMEROUS LOW-SPEED EVENTS AND 6 PUMP STOPS WHILE THE VAD WAS TETHERED TO A PATIENT CABLE AND POWER MODULE. BASED ON PAST HISTORY AND SIMILARLY REPORTED EVENTS, THE DATA CAPTURED IN THE LOG FILE IS POTENTIALLY CONSISTENT WITH A DAMAGED WIRE IN THE PATIENT¿S DRIVELINE; HOWEVER, A SPECIFIC CAUSE FOR THE LOW SPEED AND PUMP STOP EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PER THE VAD COORDINATOR, THE PATIENT REQUESTED FOR NO REPAIR TO BE PERFORMED. THEY PREFERRED TO GO HOME WITH AN UNGROUNDED PATIENT CABLE RATHER THAN HAVE AN INTERVENTION. AN ADDITIONAL LOG FILE SUBMITTED AFTER THE PATIENT WAS PROVIDED AN UNGROUNDED PATIENT CABLE CAPTURED NO FURTHER LOW SPEED OR PUMP STOPPAGE EVENTS. THE PUMP APPEARED TO BE OPERATING AS EXPECTED AFTER THE PATIENT WAS PLACED ON AN UNGROUNDED CABLE. THE PATIENT REMAINS ONGOING ON VAD SUPPORT USING AN UNGROUNDED PATIENT CABLE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS ALSO REPORTED THAT THERE WAS A TEAR IN THE PATIENT'S DRIVELINE WITH NO OBVIOUS WIRE DAMAGE.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 3 YEARS. THE PATIENT REMAINS ON VAD SUPPORT WITH THE USE OF AN UNGROUNDED PATIENT CABLE FOR POWER MODULE SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2018 WITH THE LVAD SYSTEM INDICATING PUMP STOPPAGE EVENTS. THE PATIENT WAS STABLE AND ON AN UNGROUNDED PATIENT CABLE FOR POWER MODULE CONNECTION. REVIEW OF THE LOG FILE SUBMITTED TO THE MANUFACTURER'S TECHNICAL SERVICES DEPARTMENT FOR ANALYSIS CONFIRMED MULTIPLE PUMP STOPPAGES AND PUMP SPEED DECELERATIONS. X-RAY IMAGES REVIEWED APPEARED UNREMARKABLE OTHER THAN FOR AN AREA WITH SOME SHIELD SEPARATION. AN UNGROUNDED POWER MODULE PATIENT CABLE WAS ISSUED FOR USE WHILE THE PATIENT WAS ON POWER MODULE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891387 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention