BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 11485815 · Received March 15, 2021

    Report

    Report Number
    2916596-2021-00954
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    January 24, 2021
    Report Date
    March 15, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARMS WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILE. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 6 DAYS OF DATA ((B)(6)2021 ¿ (B)(6) 2021 PER THE TIMESTAMP). INTERMITTENT NO EXTERNAL POWER ALARMS WERE CAPTURED THROUGHOUT THE LOG FILE DUE TO BOTH SYSTEM CONTROLLER POWER CABLES BEING DISCONNECTED FROM POWER. THE ALARMS RESOLVED EACH TIME WHEN THE CONTROLLER POWER CABLE WAS RECONNECTED TO AN EXTERNAL POWER SOURCE. THE SYSTEM CONTROLLER BACKUP BATTERY SUPPORTED THE SYSTEM WITHOUT ANY ISSUES DURING ALL LOSSES OF EXTERNAL POWER. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THE SYSTEM CONTROLLER WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THE REPORTED NO EXTERNAL POWER ALARM WAS DETERMINED TO BE BOTH SYSTEM CONTROLLER POWER CABLES BEING DISCONNECTED FROM EXTERNAL POWER AT THE SAME TIME. THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) AND HEARTMATE 3 PATIENT HANDBOOK EXPLAIN THE VARIOUS WAYS TO POWER THE HEARTMATE 3 LVAS. THE IFU AND PATIENT HANDBOOK EXPLAIN HOW TO SWITCH POWER SOURCES, AND STATE THAT AT LEAST ONE SYSTEM CONTROLLER POWER CABLE MUST BE CONNECTED TO A POWER SOURCE AT ALL TIMES. THE IFU AND PATIENT HANDBOOK ALSO INFORM THE USER NOT TO RELY ON THE CONTROLLER¿S BACKUP BATTERY, AS IT WILL ONLY POWER THE PUMP FOR A LIMITED AMOUNT OF TIME. THE DEVICE HISTORY RECORDS WERE REVIEWED (SHOP ORDERS 168763, 171007, AND 172849) AND THE RECORDS REVEALED THAT THE HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(4), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 31MAY2016 VIA CUSTOMER ORDER S176975. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING NO EXTERNAL POWER, LOW VOLTAGE AND BACKUP BATTERY FAULT ALARMS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 3 ¿ ¿POWERING THE SYSTEM¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 3 ¿ ¿POWERING THE SYSTEM¿ EXPLAINS 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 AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE LOW VOLTAGE AND NO EXTERNAL POWER ALARMS. REVIEW OF THE LOG FILE, CAPTURED NO EXTERNAL POWER ALARMS ON (B)(6) 2021 WHEN CONNECTED TO BATTERIES. IT APPEARED THAT THE ISSUE WAS DUE TO BOTH POWER LEADS DISCONNECTED SIMULTANEOUSLY. ON (B)(6) 2021 THE LOG CAPTURED NO EXTERNAL POWER ALARMS WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU). IT APPEARED THE ISSUE WAS DUE TO BOTH POWER LEADS BEING DISCONNECTED SIMULTANEOUSLY. IN ADDITION, NOTED SOME LOW POWER ADVISORIES DUE TO THE BATTERIES BEING ALMOST DEPLETED. FURTHER REVIEW OF THE SUBMITTED LOG FILE REVEALED AN ATYPICAL LOW VOLTAGE ADVISORY ALARM WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) THAT ACTIVATED DUE TO BOTH THE WHITE AND BLACK POWER CABLE RSOC (RELATIVE STATE-OF-HEALTH) VOLTAGES DROPPING TO APPROXIMATELY 1.4V. THE BUS VOLTAGES WERE AT THEIR EXPECTED VALUES WHILE CONNECTED TO THE MPU. THE ALARM WAS CONSISTENT WITH THE SYSTEM CONTROLLER POWER CABLES BEING INCORRECTLY CONNECTED TO THE OPPOSITE MPU POWER CABLE CONNECTORS (BLACK POWER CABLE WAS CONNECTED TO WHITE POWER CABLE AND VICE VERSA). THERE HAVE BEEN NO FURTHER NO EXTERNAL POWER ALARMS. THERE HAVE BEEN SOME CONTINUED LOW VOLTAGE ALARMS, BUT THE PATIENT BELIEVED THESE OCCURRED WHEN THE PATIENT DID NOT SWITCH OVER TO THE MPU AT NIGHT. THE MPU WAS STILL IN USE AT TIME OF REPORTED EVENT. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2021-00850.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383848 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR