BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11712365 · Received April 22, 2021

    Report

    Report Number
    2916596-2021-01993
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 27, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE REPORT OF LOW FLOW ALARMS. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE PATIENT'S FLUID STATUS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, THE ACCOUNT REPORTED THAT THE SOURCE OF THE REPORTED INFECTION WAS NOT CONSIDERED TO BE DEVICE-RELATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH EVIDENCE OF AN BACTEREMIA. WHILE IN THE HOSPITAL, THE PATIENT EXPERIENCED RECURRENT OVERNIGHT LOW FLOW ALARMS AND EARLY MORNING ALARMS ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH FLUID INTAKE, WHICH RESOLVED THE ALARMS. THE PATIENT WAS TREATED WITH OUTPATIENT INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS REPORTEDLY STABLE. THE SYSTEM CONTROLLER EVENT LOG FILE, WHICH CONTAINS DATA FROM (B)(6) (2021, CAPTURES TRANSIENT LOW FLOW ALARMS. OF NOTE, PULSATILITY INDEX VALUES WERE ELEVATED DURING THE LOW FLOW EVENTS. THE PUMP APPEARED TO OPERATE AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-023427 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. SECTION 1 "INTRODUCTION" OF THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) (REV. C) LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS, INCLUDING INFECTION (LOCALIZED, DRIVELINE, AND PUMP POCKET OR PSEUDO POCKET INFECTION), AND PROVIDES INFORMATION ON PUMP PARAMETERS, INCLUDING FLOW. SECTION 4 "SYSTEM MONITOR" PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW BECOMES TOO LOW, AND ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS HYPOVOLEMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THIS SECTION ALSO PROVIDES INFORMATION ON CONTROLLING INFECTION. HEARTMATE 3 LVAS PATIENT HANDBOOK (REV. C): SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ PROVIDES SOME INSTRUCTIONS ON HOW TO PREVENT INFECTION, INCLUDING KEEPING THE HANDS AND DRIVELINE SITE CLEAN. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAUSE OF THE LOW FLOW ALARMS WAS IDENTIFIED AND THE ALARMS RESOLVED WITH FLUID INTAKE. IT WAS REPORTED THAT THE PATIENT IS STABLE WITH BACTEREMIA. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AS AN OUTPATIENT. THE TYPE OF INFECTION WAS IDENTIFIED AS KLEBSIELLA VARIICOLA AND WAS REPORTED TO BE NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOG FILES WERE OBTAINED FOLLOWING RECURRENT OVERNIGHT LOW FLOW ALARMS FROM PATIENT. PATIENT WAS ADMITTED FOR EVIDENCE OF BACTEREMIA AND THERE ARE NO CONCERNS FOR LVAD DYSFUNCTION AT THAT TIME. THE EVENT LOG CAPTURED LOW FLOW EVENTS EARLY IN THE DAY ON (B)(6) 2021 WITH FLOW NOTED AS LOW AS 1.8 LPM. THESE OCCUR AT TIMES WHEN PI IS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607996 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7630518 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R