BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 9411079 · Received December 4, 2019

    Report

    Report Number
    2916596-2019-05491
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 8, 2019
    Report Date
    February 18, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED PUMP STOPPAGE WAS CONFIRMED THROUGH THE REVIEW OF THE LOG FILE SUBMITTED BY THE ACCOUNT. BASED ON EXPERIENCE WITH THE HMII LVAS AND SIMILAR REPORTED EVENTS, THE PUMP STOPPAGE AND HAZARD ALARMS THAT OCCURRED WHILE THE PATIENT WAS SUPPORTED BY BATTERY POWER COULD BE INDICATIVE OF DRIVELINE DAMAGE. THE SUBMITTED LOG FILE CONTAINED DATA FROM ON (B)(6) 2019 AND CAPTURED A PUMP STOPPAGE ON (B)(6) 2019 WITH CORRESPONDING HAZARD ALARMS FOR LOW SPEED AND LOW FLOW. THE PUMP STOPPAGE OCCURRED WHILE THE SYSTEM WAS SUPPORTED BY BATTERY POWER. NO OTHER ATYPICAL ALARMS OR EVENTS WERE CAPTURED. THE ACTUAL SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE REMAINDER OF THE LOG FILE AND THE PUMP APPEARED TO BE FUNCTIONING AS INTENDED. THE ACCOUNT COMMUNICATED THAT A PUMP STOP WAS OBSERVED DURING DEVICE INTERROGATION. THE PATIENT REPORTEDLY ALREADY HAD A SPLICED DRIVELINE (REFER TO COMPLAINT#: (B)(4); CS-092970; WORK ORDER#: (B)(4) MAKING AN ADDITIONAL REPAIR UNLIKELY. THE ACCOUNT REPORTED THAT THE PATIENT DID HAVE SIMILAR ALARMS 1.5-2 YEARS AGO (REFER TO COMPLAINT#: (B)(4); CS-092970 & (B)(4); CS-125271). ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NOT HAD ANY FURTHER PUMP STOPS AS OF ON (B)(6) 2019, BUT DRIVELINE DAMAGE WAS SUSPECTED. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2020 (REFER TO (B)(4); CS-133695). HEARTMATE II LVAS, SERIAL NUMBER: (B)(6), WAS NOT RETURNED FOR EVALUATION. THE HEARTMATE II LVAS IFU OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THIS IFU ALSO OUTLINES THE INDICATIONS OF DRIVELINE DAMAGE, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿, HOWEVER, ALL HEARTMATE II LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. 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 THE PATIENT LOG FILE WAS SUBMITTED FOR REVIEW DUE TO REPORTED LOW FLOW, LOW SPEED AND PUMP STOP ALARMS. THE PATIENT HAS A REPORTED SPLICED DRIVELINE. LOG FILE SUBMITTED REVEALED A PUMP STOPPAGE ON (B)(6) 2019 AT 8:19AM. THE DURATION OF EVENT WAS APPROXIMATELY 3 SECONDS AND RESULTED IN LOW SPEED, LOW FLOW AND PUMP STOP ALARMS. THE ALARMS OCCURRED WHILE THE PATIENT WAS ON BATTERY POWER WHICH WOULD INDICATE THERE IS NOW MULTIPLE DRIVELINE WIRES THAT ARE DAMAGED AND SHORTING OUT WITH EACH OTHER. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAS NOT HAD ANY FURTHER PUMP STOPS; HOWEVER, THEY ARE UNABLE TO FIND OUT ANY REASON FOR THAT PUMP STOP OTHER THAN A DRIVELINE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202780 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization