BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12338846 · Received August 18, 2021

    Report

    Report Number
    2916596-2021-04254
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 25, 2021
    Report Date
    October 27, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: CORRECTED EVENT DESCRIPTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN HEARTMATE II (HMII) LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) AND THE REPORTED EVENTS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT HAD SUSPECTED DRIVELINE DAMAGE. THE PATIENT¿S WIFE THOUGHT THAT SHE HEARD 2 BEEPS DURING THE NIGHT WHILE THE PATIENT WAS CONNECTED TO THE MPU WITH A NON-GROUNDED CABLE. A REVIEW OF THE SUBMITTED LOG FILE REVEALED NO ATYPICAL ALARMS OR EVENTS. THIS FILE APPEARED TO SHOW THE PUMP OPERATING AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT THE BREAK IN THE DRIVELINE IS STILL SUSPECTED AT THIS TIME. THE PATIENT HAS CONTINUED TO USE THE UNGROUNDED CABLE AND BATTERIES. THERE HAVE BEEN NO FURTHER ALARMS ON THE UNGROUNDED CABLE. DUE TO HOSPITAL PROTOCOL NO FURTHER INFORMATION CAN BE RELEASED AT THIS TIME. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2013. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) , REV. H AND THE HEARTMATE II PATIENT HANDBOOK, REV. G ARE CURRENTLY AVAILABLE. SECTIONS 6 AND 8 OF THE HMII IFU, AS WELL AS SECTIONS 4 AND 6 OF THE HMII PATIENT HANDBOOK, PROVIDE INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE AND ADDRESS DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THESE SECTIONS STATE THAT DESPITE CARE, ALL HEARTMATE II DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON DURATION OF USE AND MOVEMENT/FLEXING OVER TIME. ADDITIONALLY, THESE SECTIONS OUTLINE INDICATIONS OF DRIVELINE DAMAGE AS WELL AS THE HOW TO RESPOND TO SUCH EVENTS. FURTHERMORE, SECTION 7 OF THE HMII IFU AND SECTION 5 OF THE HMII PATIENT HANDBOOK ADDRESS ALL HAZARD AND ADVISORY ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE PATIENT HANDBOOK ALSO CONTAINS A SECTION ON HANDLING EMERGENCIES AND FURTHER INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT IF THE PATIENT THINKS THAT, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH A SUSPECTED BREAK IN THE HEARTMATE II (HM II) DRIVELINE. THE PATIENT'S WIFE THOUGHT THAT SHE HEARD TWO SHORT BEEPS DURING THE NIGHT WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) WHILE ON A NON-GROUNDED CABLE. THE LOG FILE ANALYSIS SHOWED MULTIPLE PULSATILITY INDEX (PI) EVENTS THROUGHOUT THE LOG. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MCS EQUIPMENT IS OPERATING AS INTENDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH A SUSPECTED BREAK IN THE HEARTMATE II (HM II) DRIVELINE. THE PATIENT'S WIFE THOUGHT THAT SHE HEARD TWO SHORT BEEPS DURING THE NIGHT WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) THAT HAS A HISTORY OF A NON-GROUNDED CABLE. THE LOG FILE ANALYSIS SHOWED MULTIPLE PULSATILITY INDEX (PI) EVENTS THROUGHOUT THE LOG. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MCS EQUIPMENT IS OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236318 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR