BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12416368 · Received September 2, 2021

    Report

    Report Number
    2916596-2021-04787
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    July 17, 2021
    Report Date
    November 19, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE ANALYSIS OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED SYSTEM STOPPAGE AND ASSOCIATED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THIS EVENT COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS INVESTIGATION. THE SUBMITTED SYSTEM CONTROLLER EVENT LOG FILE CONTAINED DATA FROM (B)(6)2021 THROUGH (B)(6) 2021. AT THE BEGINNING OF THE FILE ON (B)(6) 2021 AT 06:53:02, THE PUMP WAS STOPPED, WITH THE PUMP SPEED OBSERVED AT 0 REVOLUTIONS PER MINUTE (RPM). DATA PRIOR TO THE PUMP STOP EVENT WAS OVERWRITTEN BY NEW DATA. LOW FLOW, LOW SPEED, AND LEFT VENTRICULAR ASSIST DEVICE (LVAD) OFF ALARMS WERE ASSOCIATED WITH THE EVENT. APPROXIMATELY TWO SECONDS LATER AT 06:53:04, THE PUMP STARTED TO RAMP BACK UP TO ITS SET SPEED AND APPEARED TO OPERATE AS INTENDED AT THE SET SPEED FOR THE DURATION OF THE FILE. NO OTHER NOTABLE ALARMS WERE OBSERVED WITHIN THE FILE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SENT TO THE ACCOUNT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-021438. NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. 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 08JUN2020. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS. SECTION 4 ALSO EXPLAINS THAT THE LOW FLOW HAZARD ALARM IS TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM). SECTION 7 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS (INCLUDING PUMP STOP AND LOW FLOW ALARMS), AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO AVAILABLE. SECTION 5 ENTITLED "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE PATIENT HANDBOOK CAUTIONS THE USERS 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.

    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 HAD LOW FLOW ALARMS WITH A PUMP STOP NOTED ON (B)(6) 2021. THE LOG FILE SHOWED THE PUMP STOP ON (B)(6) 2021. THE CAUSE OF THE PUMP STOP WAS UNABLE TO BE IDENTIFIED BECAUSE THE DATA SURROUNDING IT WAS OVERWRITTEN BY NEWER DATA. THE PATIENT DENIED AUDIBLE ALARMS OR ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314790 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7464241 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male