BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9694551 · Received February 11, 2020

    Report

    Report Number
    2916596-2020-00443
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 23, 2020
    Report Date
    March 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORAMTION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF AN OUTFLOW GRAFT KINK COULD NOT BE CONFIRMED AS NO IMAGES WERE PROVIDED BY THE ACCOUNT AND NO PRODUCT WAS RETURNED FOR EVALUATION. ADDITIONALLY, LOW FLOW ALARMS WERE CONFIRMED THROUGH THE LOG FILES PROVIDED BY THE ACCOUNT. ALTHOUGH A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED, THE ACCOUNT STATED THAT PUMP FUNCTION RETURNED TO NORMAL PARAMETERS FOLLOWING THE CORRECTIVE SURGERY. FURTHERMORE, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER MLP-011537, AND THE REPORTED HEPATIC DYSFUNCTION COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED APPROXIMATELY 2 HOURS OF DATA FROM 23JAN2020. LOW FLOW FAULT FLAGS WERE CAPTURED THROUGHOUT THE FILE WHEN THE ESTIMATED FLOW DROPPED BELOW THE THRESHOLD OF 2.5 LPM. THESE FAULTS RESULTED IN 28 LOW FLOW HAZARD ALARMS WHICH LASTED BETWEEN 1 AND 57 SECONDS, EACH, AND DID NOT APPEAR TO BE ASSOCIATED WITH ELEVATED PI VALUES. NO OTHER ATYPICAL EVENTS WERE CAPTURED. DESPITE THE OBSERVED ALARMS, THE PUMP APPEARED TO FUNCTION AS INTENDED AND OPERATED AT OR ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER MLP-011537, AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HM3 LVAS IFU LISTS HEPATIC DYSFUNCTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND CAUTIONS THE USER NOT TO ROTATE/TWIST THE GRAFT. THE IFU INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THIS DOCUMENT ALSO STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. ADDITIONALLY, THE IFU DESCRIBES ALL ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED OUTFLOW GRAFT OBSTRUCTION COULD NOT BE CONFIRMED AS NO IMAGES WERE PROVIDED BY THE ACCOUNT AND NO PRODUCT WAS RETURNED FOR EVALUATION. ADDITIONALLY, LOW FLOW ALARMS WERE CONFIRMED THROUGH THE LOG FILES PROVIDED BY THE ACCOUNT. ALTHOUGH A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED, THE ACCOUNT STATED THAT PUMP FUNCTION RETURNED TO NORMAL PARAMETERS FOLLOWING THE CORRECTIVE SURGERY. FURTHERMORE, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED HEPATIC DYSFUNCTION COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED APPROXIMATELY 2 HOURS OF DATA FROM 23JAN2020. LOW FLOW FAULT FLAGS WERE CAPTURED THROUGHOUT THE FILE WHEN THE ESTIMATED FLOW DROPPED BELOW THE THRESHOLD OF 2.5 LPM. THESE FAULTS RESULTED IN 28 LOW FLOW HAZARD ALARMS WHICH LASTED BETWEEN 1 AND 57 SECONDS, EACH, AND DID NOT APPEAR TO BE ASSOCIATED WITH ELEVATED PI VALUES. NO OTHER ATYPICAL EVENTS WERE CAPTURED. DESPITE THE OBSERVED ALARMS, THE PUMP APPEARED TO FUNCTION AS INTENDED AND OPERATED AT OR ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE HM3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS HEPATIC DYSFUNCTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND CAUTIONS THE USER NOT TO ROTATE/TWIST THE GRAFT. THE IFU INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THIS DOCUMENT ALSO STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. ADDITIONALLY, THE IFU DESCRIBES ALL ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. 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 22OCT2018 THE HEARTMATE 3 LVAS IFU, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS HEPATIC DYSFUNCTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 OF THE IFU ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THIS IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 7, "ALARMS AND TROUBLESHOOTING", DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD ALARM, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS THAT PRIOR TO IMPLANTATION, THE BEND RELIEF SHOULD BE DISENGAGED FROM THE GRAFT FOR THE DE-AIRING PROCEDURE. SECTION 5 ALSO CONTAINS A SUB-SECTION ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP", INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 5, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." THIS SECTION ALSO EXPLAINS HOW TO ATTACH THE BEND RELIEF ONCE THE VENT NEEDLE HAS BEEN REMOVED FROM THE SEALED OUTFLOW GRAFT AND LEAKS HAVE BEEN RULED OUT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE PATIENT UNDERWENT SURGERY ON (B)(6) 2020. THE BEND RELIEF WAS OPENED AND RESECTED. THE PUMP PARAMETERS RETURNED TO NORMAL AFTER THE SURGERY. THE ETIOLOGY OF THE PUMP MALFUNCTION WAS BELIEVED TO BE DUE TO KINKING OF THE OUTFLOW GRAFT. THE PATIENT IS CURRENTLY IN CV SURGERY WARD AND IS DOING WELL.

    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 WAS ADMITTED FOR SHORTNESS OF BREATH, ACUTE JAUNDICE, AND ELEVATED LIVER FUNCTION TESTS (LFT). FLOWS ON MONDAY WERE NOTED BE 2 LPM LOWER THAN AVERAGE. FLOWS ON (B)(6) 2020 WERE LESS THAN 2.5 LPM. THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE MANUFACTURER'S TECHNICAL SERVICE REPRESENTATIVE REVIEWED THE LOG FILE AND CONFIRMED MULTIPLE LOW FLOW ALARMS. THE PERIODIC LOG INDICATES THAT THE CALCULATED FLOW APPEARS TO HAVE STARTED A DOWNWARD TREND AROUND (B)(6) 2020. CT ANGIOGRAM SHOWED A CLOT PROXIMAL TO THE OUTFLOW GRAFT. THE PATIENT WILL UNDERGO SURGERY TO CORRECT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154558 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6625048 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R