BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 12449876 · Received September 9, 2021

    Report

    Report Number
    2916596-2021-04717
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 11, 2021
    Report Date
    November 30, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE SUBMITTED LOG FILE WAS REVIEWED FOLLOWING THE REPORTED EVENT OF LOW FLOW ALARMS. THE LOW FLOW ALARMS ARE ADDRESSED UNDER THE PUMP INVESTIGATION (MFR REPORT NUMBER 2916596-2021-04716). THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 8 HOURS OF DATA ((B)(6) 2021 AT 14:53:43 TO 22:27:13 PER THE TIMESTAMP). THE LOG FILE CAPTURED A LOW FLOW ALARM ON 11AUG2021 FROM 19:41:20 TO 20:37:12; THESE ALARMS ARE ADDRESSED UNDER THE PUMP INVESTIGATION. THE DATA IN THE LOG FILE DID NOT INDICATE ANY ISSUES WITH THE SYSTEM CONTROLLER. NO OTHER NOTABLE ALARMS WERE OBSERVED. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2021 AT 20:38:01 TO EXCHANGE THE SYSTEM CONTROLLER. THE ALARM DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THE SYSTEM CONTROLLER WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED COMMUNICATED THAT THE EXCHANGED SYSTEM CONTROLLER WAS NOW BEING USED AS THE PATIENT¿S BACKUP CONTROLLER. THERE WERE NO REPORTED ISSUES WITH THE SYSTEM CONTROLLER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT (B)(6) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 24OCT2018. THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND THE HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (AUDITORY AND VISUAL), INCLUDING LOW FLOW ALARMS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. THE HEARTMATE 3 PATIENT HANDBOOK AND THE HEARTMATE 3 IFU ALSO CAUTION THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT ON 28SEP2021, THE PATIENT HAD A LOW FLOW SOFTWARE UPGRADE DUE TO PARTIAL LEFT VENTRICLE RECOVERY. THE PATIENT REMAINED PULSATILE AND WAS ASYMPTOMATIC WITH THE PERSISTENT LOW FLOW ALARMS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2021-04716. IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT EXPERIENCED SUDDEN AND CONTINUOUS LOW FLOWS AROUND 1LPM. IT WAS LATER NOTED ON COMPUTED TOMOGRAPHY (CT) THAT THE PATIENT HAD AN OUTFLOW OBSTRUCTION. THE PATIENT'S SYSTEM CONTROLLER WAS SWITCHED IN THE FIELD TO RULE OUT MECHANICAL FAILURE BY THE SYSTEM CONTROLLER. A REVIEW OF THE LOG FILES BY TECHNICAL SERVICES CONFIRMED THE REPORTED LOW FLOWS, AND IT WAS NOTED THAT THE BLOCKAGE AT THE OUTFLOW WOULD CAUSE THE FLOW TO DROP. THE PATIENT'S VITAL SIGNS WERE STABLE, WITH HEART RATE IN THE 70-80S BPM, BLOOD PRESSURES RANGING FROM 100/60 (MMHG) TO 120/80 (MMHG), AND MEAN ARTERIAL PRESSURES (MAPS) RANGING FROM 70-90 MMHG. THE PATIENT REMAINED ASYMPTOMATIC, ALTHOUGH IMAGING CONFIRMED BLOCKAGES THAT WERE NONTHROMBOTIC. THE PATIENT REMAINED ON THE BACKUP SYSTEM CONTROLLER, WHICH PERFORMED THE SAME AS THE PRIMARY. ON (B)(6) 2021, 6 OUTFLOW GRAFT STENTS WERE PLACED, AND THE PATIENT'S FLOWS RETURNED TO 3-4 LPM AFTER THE STENT PLACEMENT. LOW FLOW ALARMS RETURNED LATER, PERSISTENT AROUND 1315 ON (B)(6) 2021, WHICH ARE NOT ABNORMAL AS THE PATIENT HAS SOME DEGREE OF LEFT VENTRICLE RECOVERY. A REVIEW OF SUBMITTED LOG FILES BY TECHNICAL SERVICES FOUND LOW FLOWS INTERMITTENT WITH HIGH PULSATILITY INDEX (PI) EVENTS, WHICH SEEMED TO BE PHYSIOLOGICAL IN NATURE. THE PUMP WAS SEEING A REDUCTION IN BLOOD VOLUME. THERE WERE NO OTHER UNUSUAL EVENTS WITHIN THE LOG FILES, AND THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345725 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531 6588100

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male