BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 14547945 · Received May 31, 2022

    Report

    Report Number
    2916596-2022-11015
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 27, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: THE LOG FILE CAPTURED THE BACKUP BATTERY BEING UNINSTALLED ON 10MAY2022 AT 04:02:31 AND A REPLACE SYSTEM CONTROLLER ALARM ASSOCIATED WITH A BACKUP PROCESSOR FAULT. THE HEARTMATE II SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS RETURNED FOLLOWING THE REPORTED EVENTS OF A PUMP STOP, DRIVELINE DISCONNECTS AND THE SYSTEM MONITOR REBOOTING; THE SYSTEM MONITOR TURNING OFF WILL BE INVESTIGATED UNDER THE PUMP AND ARE ADDRESSED VIA PI-2022-0071346-01. THE SUBMITTED LOG FILE AND THE LOG FILE DOWNLOADED FROM THE RETURNED HEARTMATE II SYSTEM CONTROLLER CONTAINED APPROXIMATELY 14.5 DAYS OF DATA COMBINED (25APR2022 ¿ 10MAY2022 AND 01JAN2001 PER THE TIMESTAMP). THE LOW SPEED ADVISORY/HAZARD, LOW FLOW HAZARD AND DRIVELINE DISCONNECT ALARMS WERE CAPTURED FROM THE 10MAY2022 FROM 5:59:00 TO 6:40:28; THESE EVENTS APPEAR TO BE CONSISTENT WITH ISSUES ON THE DRIVELINE AS PHASES 1 AND 3 VALUES WERE DECREASED DURING THESE EVENTS. THE DRIVELINE WAS CAPTURED TO BE DISCONNECTED AGAIN ON 10MAY2022 AT 6:40:28; THIS EVENT APPEARS TO BE CONSISTENT WITH THE CONTROLLER BEING EXCHANGED AS THE DRIVELINE WAS NOT RECONNECTED THROUGHOUT THE REMAINDER OF THE LOG FILE. ASIDE FROM THE NOTED EVENTS, THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT WHILE THE DRIVELINE WAS CONNECTED. THE REPORTED EVENTS COULD NOT BE CORRELATED TO AN ISSUE WITH THE CONTROLLER. IT SHOULD BE NOTED THAT THE HEARTMATE II SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 18 DECEMBER 2017. THE PRODUCT LIFE OF A SYSTEM CONTROLLER IS A MINIMUM OF 3 YEARS FROM THE DATE OF FIRST USE. HEARTMATE II PATIENT HANDBOOK (REV. C) SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE II INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE REPLACE SYSTEM CONTROLLER, LOW SPEED ADVISORY/HAZARD, LOW FLOW HAZARD, PUMP STOP AND DRIVELINE DISCONNECT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE II PATIENT HANDBOOK (REV. C) SECTION 2, ENTITLED "HOW YOUR HEART PUMP WORKS", INCLUDES THE SUBSECTION ENTITLED ¿THE SYSTEM CONTROLLER USER INTERFACE¿. THIS SUBSECTION DESCRIBES THAT THE USER INTERFACE ON THE SYSTEM CONTROLLER USES SOUNDS, LIGHTS, SYMBOLS, AND ON-SCREEN MESSAGES TO TELL YOU HOW THE SYSTEM IS WORKING. THIS SUBSECTION ALSO DESCRIBES THAT ON-SCREEN MESSAGES ALSO TELL YOU HOW TO HANDLE ALARMS AND OTHER SITUATIONS. HEARTMATE II PATIENT HANDBOOK (REV. C) SECTION 6, ENTITLED "CARING FOR THE EQUIPMENT", DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER. SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE II LVAD, INCLUDING THE SYSTEM CONTROLLER AND THE SYSTEM CONTROLLER POWER CABLES. THIS SECTION ALSO INDICATES THAT THE BACKUP BATTERY SHOULD BE REPLACED 6 MONTHS BEFORE THE BACKUP BATTERY EXPIRES. HEARTMATE II INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION 4, ENTITLED ¿SYSTEM MONITOR¿, EXPLAINS HOW TO HOW TO VIEW THE BACKUP BATTERY INFORMATION ON SYSTEM MONITOR, INCLUDING THE MANUFACTURE DATE AND THE NUMBER OF MONTHS UNTIL THE BACKUP BATTERY NEEDS TO BE REPLACED. SECTION 2 ¿SYSTEM OPERATIONS¿ UNDER ¿SYSTEM CONTROLLER BACKUP BATTERY POWER¿ INFORMS THE USER THAT THE BACKUP BATTERY HAS A LIMITED LIFESPAN OF 36 MONTHS FROM THE MANUFACTURE DATE. THE HEARTMATE II PATIENT HANDBOOK (REV. C) CAUTIONS 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE HEARTMATE II SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE II SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 18DEC2017. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING HEART TRANSPLANT HE PATIENT HAD A PUMP STOP AND THE SYSTEM MONITOR ALARMED TO CONNECT DRIVELINE DESPITE ALL CONNECTIONS BEING INTACT. THE SYSTEM MONITOR SHUT DOWN AND REBOOTED AS WELL DURING THIS TIME. LOG FILE REVIEW FOUND AN ONSET OF LOW SPEED HAZARD, LOW FLOW HAZARD, AND HIGH POWER EVENTS ON (B)(6) 2022 BETWEEN 5:59 AM AND 6:40 AM. TWO OF THE THREE PUMP PHASES CONTAINED A SIGNIFICANT DROP IN VALUES WHICH INDICATED POSSIBLE DRIVELINE COMPROMISE. IT WAS UNKNOWN IF THE PATIENT HAD ANY DRIVELINE DAMAGE PRIOR TO TRANSPLANT BUT THE TRANSPLANT WAS NOT RELATED TO ANY DEVICE ISSUES. RELATED MANUFACTURER'S REPORT REGARDING THE PUMP: 2916596-2022-11014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881970 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other