BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12259126 · Received August 2, 2021

    Report

    Report Number
    2916596-2021-04216
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 6, 2021
    Report Date
    October 21, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF LOW FLOW EVENTS WAS CONFIRMED THROUGH EVALUATION OF THE SUBMITTED LOG FILES. A DIRECT CORRELATION BETWEEN (B)(6) AND THE CAUSE OF THE LOW FLOW EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THE SYSTEM CONTROLLER WAS REPORTING VALUES OF ZERO FLOW. TECHNICAL SERVICES REVIEWED THE SUBMITTED LOG FILES AND REVEALED A SUDDEN DROP IN ESTIMATED FLOW ON (B)(6) 2021 11:36:00 THROUGH (B)(6) 2021 13:23:00. ADDITIONAL INFORMATION FROM THE VAD COORDINATOR REVEALED THAT THE PATIENT WAS FEELING WELL, AND THEIR FLOWS WERE BACK TO NORMAL. THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2021 WHICH DID NOT REVEAL ANY EVIDENCE OF THROMBUS OR BIO DEBRIS IN THE DEVICE. IT WAS REPORTED THE LOW FLOW ALARMS RESOLVED AFTER EXCHANGING THE SYSTEM CONTROLLER AND MODULAR CABLE. THE CONTROLLER EVENT LOG FILE CAPTURED 76 LOW FLOW FAULTS ON (B)(6) 2021 11:35:56 THROUGH 13:23:12 WHEN THE FLOW DROPPED AS LOW AS 0.0 LPM, BELOW THE LOW FLOW THRESHOLD OF 2.0 LPM. OF THESE FAULTS, 70 LASTED LONG ENOUGH TO TRIGGER A LOW FLOW ALARM. ON (B)(6) 2021 11:36:06 THE FLOW DROPPED FROM 4.3 LPM TO 0.0 LPM. THE REPORTED FLOW WAS 0.0 LPM UNTIL (B)(6) 2021 13:00:20. THE FLOW VALUES REMAINED LOW FOR THE REMAINDER OF THE LOG FILE. THE DEVICE OPERATED ABOVE THE LOW-SPEED LIMIT FOR THE DURATION OF THE LOG FILE. THE CONTROLLER PERIODIC LOG FILE CAPTURED 2 LOW FLOW ALARMS ON (B)(6) 2021 12:25:17 AND (B)(6) 2021 13:25:16 WHEN THE FLOW DROPPED TO 0.0 LPM. THE DEVICE OPERATED ABOVE THE LOW-SPEED LIMIT FOR THE DURATION OF THE LOG FILE. THE LVAD EVENT LOG FILE CONTAINED LOW FLOW VALUES FROM (B)(6) 2021 11:35:55 THROUGH (B)(6) 2021 13:23:06. NO OTHER ALARMS WERE OBSERVED. THE LVAD PERIODIC LOG FILE CONTAINED LOW FLOW VALUES THAT WERE CAPTURED ON (B)(6) 2021 12:02:56 AND (B)(6) 2021 13:02:58. NO OTHER ALARMS WERE CAPTURED. THE PATIENT REMAINS ONGOING WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). THE HEARTMATE 3 LVAS IFU EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING AND OUTLINES ALL PUMP PARAMETERS. THIS DOCUMENT ADDITIONALLY OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING LOW FLOW ALARMS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THE HEARTMATE 3 PATIENT HANDBOOK STATES THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL THE HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. THE CURRENT HEARTMATE 3 LVAS IFU CONTAINS A SECTION ON ¿PUMP PERFORMANCE MONITORING¿ UNDER PATIENT CARE AND MANAGEMENT WHICH EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. SECTION 4.4 ¿CLINICAL SCREEN¿ CONTAINS SECTIONS ON PUMP FLOW, PUMP SPEED, PULSATILITY INDEX, AND PUMP POWER. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THE HEARTMATE 3 PATIENT HANDBOOK CONTAINS A SECTION ON ¿ALARMS AND TROUBLESHOOTING¿ WHICH PROVIDES INFORMATION ON ALL SYSTEM ALARMS AND THE ACTIONS ASSOCIATED TO RESOLVE THE ALARMS. A SECTION ON ¿HANDLING EMERGENCIES¿ IS ALSO PROVIDED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) 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.

    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 DEVICE HAD ZERO FLOW ON LOW FLOW CONTROLLER. LOG FILE ANALYSIS CONTAINED A SUDDEN DROP IN ESTIMATED FLOW STARTING @11:36AM ON (B)(6) 2021 UNTIL THE END OF THIS LOG FILE @1:23PM ON (B)(6) 2021. THE PATIENT WAS REPORTED AS DOING OKAY, FLOWS WERE BACK AND THE PATIENT GOT ADMITTED FOR A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE CONTROLLER AND MODULAR CABLE WERE SWAPPED AND THIS APPEARED TO HAVE RESOLVED THE ALARMS. THE CTA WAS PERFORMED ON (B)(6) 2021 DUE TO CONTRAST ALLERGY AND PATIENT NEEDED ADMISSION FOR STEROIDS PREMED. RELATED MFR. REPORT NUMBERS: 2916596-2021-04161 AND 2916596-2021-04162.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160223 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7671856 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization