BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 13759599 · Received March 14, 2022

    Report

    Report Number
    2916596-2022-01241
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 20, 2022
    Report Date
    March 28, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION THE REPORTED EVENT OF A DRIVELINE POWER FAULT WAS ABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS RETURNED FOR ANALYSIS, AND A LOG FILE WAS SUBMITTED FOR REVIEW AND ANOTHER WAS DOWNLOADED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 5 DAYS ((B)(6) 2022 PER TIMESTAMP). EVENTS CAPTURED ON (B)(6) 2022 TOOK PLACE IN THE TESTING LABS AT ABBOTT. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 AT 05:29:14 AND WAS RECONNECTED AT 06:15:34. FOLLOWING THE RECONNECTION, DRIVELINE POWER FAULTS COINCIDENT WITH PWR_B_BROKEN AND OCP_B_OPEN FAULTS WERE ACTIVE AND DID NOT CLEAR FOR THE REMAINDER OF THE LOG FILE. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 AT 07:50:05 AND WAS NOT CONNECTED AGAIN FOR THE REMAINDER OF THE LOG FILE. THE CONTROLLER WAS SHUT OFF AND PLACED INTO CHARGE MODE AT 07:53:08. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE CONTROLLER UNDERWENT INITIAL TESTING AND DID NOT PASS DUE TO AN OPENED FUSE B. THE FUSE WAS REPLACED AND THE CONTROLLER WAS RETESTED. THE CONTROLLER UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING AND PASSED. THE CONTROLLER WAS ABLE TO OPERATE A MOCK LOOP AND FUNCTION AS INTENDED. THE ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE CAUSE BY A 180-DEGREE CONNECTION OF THE MODULAR CABLE CAUSING THE FUSE TO OPEN. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. G, SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. G, SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDITORY), INCLUDING CONTROLLER FAULT, DRIVELINE POWER FAULT, DRIVELINE DISCONNECT, AND POWER CABLE DISCONNECT ALARMS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. HEARTMATE 3 PATIENT HANDBOOK, REV. G, SECTION 2 ¿ ¿HOW YOUR HEART PUMP WORKS¿ INSTRUCTS USERS ON HOW TO EXCHANGE THEIR SYSTEM CONTROLLER, AND STATES TO NEVER EXCHANGE THEIR SYSTEM CONTROLLER WITHOUT HAVING A TRAINED, AND COMPETENT CAREGIVER AT YOUR SIDE TO ASSIST. THE SECTION ALSO PROVIDES THE PROPER STEPS TO CONNECT THE DRIVELINE TO THE SYSTEM CONTROLLER. THIS SECTION STATES, ¿ALIGN THE WHITE ARROW/ALIGNMENT MARK ON THE DRIVELINE CABLE CONNECTOR WITH THE WHITE ARROW ON THE SYSTEM CONTROLLER DRIVELINE CONNECT¿. HEARTMATE 3 PATIENT HANDBOOK, REV. G, SECTION 4 ¿ ¿LIVING WITH THE HEARTMATE 3¿ EXPLAINS THAT THE SYSTEM CONTROLLER MUST BE KEPT DRY AT ALL TIMES AND TO NEVER SWIM OR TAKE BATHS. USERS ARE INSTRUCTED NOT TO SHOWER WITHOUT A DOCTOR¿S APPROVAL, AND TO NEVER SHOWER WITH THE SHOWER BAG. THIS SECTION ALSO STATES ¿ALTHOUGH THE EXTERNAL COMPONENTS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM ARE MOISTURE-RESISTANT, THEY ARE NOT WATERPROOF. TAKE CARE TO PROTECT SYSTEM COMPONENTS FROM WATER OR MOISTURE, WHETHER INDOORS SHOWERING OR OUTDOORS IN A HEAVY RAIN. IF THE COMPONENTS HAVE CONTACT WITH WATER OR MOISTURE, YOU MAY RECEIVE AN ELECTRICAL SHOCK OR THE PUMP MAY STOP¿. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. G, SECTION 3 ¿ ¿POWERING THE SYSTEM¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. G, SECTION 3 ¿ ¿POWERING THE SYSTEM¿ EXPLAIN THE VARIOUS WAYS TO POWER THE HEARTMATE 3 LVAS, AND HOW TO PROPERLY EXCHANGE POWER SOURCES. IT ALSO STATES THAT AT LEAST ONE SYSTEM CONTROLLER POWER CABLE MUST BE CONNECTED TO A POWER SOURCE AT ALL TIMES AND INFORMS THE USER NOT TO RELY ON THE CONTROLLER¿S BACKUP BATTERY, AS IT WILL ONLY POWER THE PUMP FOR A LIMITED AMOUNT OF TIME AND THE PUMP WILL STOP. 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. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-01240 IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SUBMITTED FOR REVIEW CONCERNING DRIVELINE COMMUNICATION FAULT ALARMS. THE PATIENT CAME TO THE EMERGENCY ROOM (ER) WITH DRIVELINE COMMUNICATION FAULT ALARMS AND PUMP STOP ALARMS. A REVIEW OF THE LOG FILE REVEALED THAT THE PATIENT WAS CONNECTED TO FULLY CHARGED BATTERIES ON (B)(6) 2022 AT 1618:28. A POWER SOURCE EXCHANGE WAS MADE AT (B)(6) 2022 AT 0527:35. THE LOG FILE INDICATED THAT THE DRIVELINE WAS DISCONNECTED FROM THE CONTROLLER ON (B)(6) 2022 AT 0529:14. WHILE THE DRIVELINE WAS STILL DISCONNECTED, THE CONTROLLER WAS CONNECTED TO MOBILE POWER UNIT (MPU) POWER ON (B)(6) 2022 AT 0546:26. WHILE THE DRIVELINE WAS STILL DISCONNECTED, THE CONTROLLER WAS SWITCHED BACK TO BATTERY POWER ON (B)(6) 2022 AT 0606:44. THE DRIVELINE WAS RECONNECTED TO THE CONTROLLER WHILE ON BATTERY POWER ON (B)(6) 2022 0615:38. MOTOR SPEED WAS INCREASED TO THE SET SPEED OF 5000 RPMS HOWEVER THE CONTROLLER INDICATED THAT THE DRIVELINE POWER FAULT WAS ASSOCIATED WITH AN OPEN FUSE IN THE SYSTEM CONTROLLER. THE LOG FILE INDICATED THE CONTROLLER¿S POWER SOURCE WAS SWITCHED FROM BATTERY POWER TO POWER MODULE POWER ON (B)(6) 2022 AT 0658:46. DRIVELINE POWER FAULT EVENTS CONTINUED. THE SYSTEM CONTINUED TO MAINTAIN ITS SET SPEED UNTIL ANOTHER DRIVELINE FAULT OCCURRED ON (B)(6) 2022 AT 0749:22. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT PASSED AWAY. THEY WERE FOUND UNRESPONSIVE AND WAS BROUGHT TO THE ER BY EMERGENCY RESPONDERS.

    Description of Event or Problem · 0

    RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2022-01745.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989991 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531US 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female