BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15136467 · Received July 29, 2022

    Report

    Report Number
    2916596-2022-12612
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 28, 2022
    Report Date
    September 2, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF INTERMITTENT LOW VOLTAGE ADVISORY ALARMS WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILES. THE LOG FILES (RONDON 20220629 113705 AND RONDON 20220713 043109) CONTAINED APPROXIMATELY 4.5 DAYS OF DATA COMBINED (28JUN2022 ¿ 29JUN2022 AND 11JUL2022 ¿ 14JUL2022 PER THE TIMESTAMP). INTERMITTENT LOW VOLTAGE ADVISORY ALARMS THAT WERE NOT ASSOCIATED WITH REGULAR BATTERY DEPLETION ACTIVATED THROUGHOUT THE LOG FILE DUE TO THE RELATIVE STATE OF CHARGE (RSOC) VOLTAGE ON THE BLACK POWER CABLE DROPPING BELOW THE LOW VOLTAGE THRESHOLD WHILE CONNECTED TO 14V BATTERIES; THE ALARM RESOLVED SHORTLY AFTER ACTIVATING EACH TIME. THERE WERE NO OTHER NOTABLE ALARMS THROUGHOUT THE LOG FILE. THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE. THE CONTROLLER HAS NOT BEEN RETURNED FOR EVALUATION TO THIS DATE. THIS FILE WILL BE REOPENED AT A LATER DATE IF THE CONTROLLER IS RETURNED TO ABBOTT FOR EVALUATION. IT WAS ALSO NOTED THAT NO FURTHER INFORMATION WILL BE PROVIDED REGARDING THIS CASE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE 3 PATIENT HANDBOOK SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE LOW VOLTAGE ADVISORY/HAZARD ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK 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 3 LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER FOR DAMAGE. HEARTMATE 3 PATIENT HANDBOOK 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 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(4), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: FLUID INGRESS COATING THE PROTECTIVE LAYERS OF THE WHITE POWER CABLE AND BLACK POWER CABLE. FLUID INGRESS ON THE INSULATION JACKET OF THE WHITE POWER CABLE AND THE BLACK POWER CABLE INNER WIRES. THE REPORTED EVENT OF INTERMITTENT LOW VOLTAGE ADVISORY ALARMS WAS CONFIRMED VIA ANALYSIS OF THE LOG FILES; HOWEVER, THE ALARMS WERE NOT REPRODUCED DURING TESTING OF THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6). THE SUBMITTED LOG FILES AND THE LOG FILE DOWNLOADED FROM THE RETURNED CONTROLLER CONTAINED APPROXIMATELY 8.5 DAYS OF DATA COMBINED (B)(6) 2022 ¿ (B)(6) 2022 AND (B)(6) 2022 ¿ (B)(6) 2022 PER THE TIMESTAMP). INTERMITTENT LOW VOLTAGE ADVISORY ALARMS THAT WERE NOT ASSOCIATED WITH REGULAR BATTERY DEPLETION ACTIVATED THROUGHOUT THE LOG FILE DUE TO THE RELATIVE STATE OF CHARGE (RSOC) VOLTAGE DROPPING BELOW THE LOW VOLTAGE THRESHOLD WHILE CONNECTED TO THE 14V BATTERIES; THE ALARM WAS OBSERVED ON BOTH POWER CABLES AND RESOLVED SHORTLY AFTER ACTIVATING EACH TIME. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 AT 11:19:00 TO EXCHANGE THE SYSTEM CONTROLLER. THERE WERE NO OTHER NOTABLE ALARMS THROUGHOUT THE LOG FILE. THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE. THE RETURNED CONTROLLER OPERATED A MOCK CIRCULATORY AT THE SET SPEED WITHOUT ANY ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE POWER CABLES WERE MANIPULATED BY HAND. RAISED RESISTANCES WERE OBSERVED ON THE ON BOTH POWER CABLES, INCLUDING THE RSOC WIRES OF BOTH POWER CABLES; THIS IS CONSISTENT WITH CONDUCTOR BREAKDOWN ON THE POWER CABLES. CONDUCTOR BREAKDOWN ON THE POWER CABLES COULD RESULT IN THE REPORTED ALARMS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS; HOWEVER, THE RAISED RESISTANCES ON THE POWER CABLES COULD HAVE CONTRIBUTED TO THE REPORTED ALARMS. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE LOW VOLTAGE ADVISORY/HAZARD ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK (REV. D) 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 3 LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER FOR DAMAGE. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 4, ENTITLED ¿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 PATIENT HANDBOOK (REV. D) 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 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 27JUN2019 . NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING MULTIPLE LOW VOLTAGE ALARMS WHILE BATTERIES HAD AT LEAST 50% CHARGE. IT WAS PLANNED TO REPLACE THE BATTERY CLIPS. LOG FILE REVIEW CONFIRMED SEVERAL ODD LOW VOLTAGE ADVISORIES WHILE ON BATTERY POWER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOW VOLTAGE ALARMS CONTINUED ON NEW CLIPS AND NEW BATTERIES. THE CONTROLLER WAS EXCHANGED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430523 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7020748 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male