BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 17454086 · Received August 3, 2023

    Report

    Report Number
    2916596-2023-05489
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 18, 2023
    Report Date
    November 13, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    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

    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 LOUD CONTINUOUS ALARM FROM THE POWER MODULE WAS CONFIRMED VIA EVALUATION. A REVIEW OF THE LOG FILE CONTAINED DATA SPANNING 3 APPROXIMATELY DAYS ((B)(6) 2022, (B)(6) 2023, (B)(6) 2000 PER TIMESTAMP). ALL OF THE CAPTURED DATA APPEARED TO SHOW THE SYSTEM CONTROLLER OPERATING AS INTENDED. THE HEARTMATE 3 SYSTEM CONTROLLER (S/N: (B)(6)) WAS RETURNED FOR ANALYSIS. DURING PRELIMINARY TESTING, THE REPORTED EVENT WAS REPRODUCED; A CONSTANT ALARM FROM THE POWER MODULE ACTIVATED AFTER CONNECTING THE CONTROLLER. NO ALARM MESSAGE WAS ACTIVE ON THE SCREEN. THE CONTROLLER WAS DISASSEMBLED IN ORDER TO EVALUATE THE PRINTED CIRCUIT BOARDS (PCB). CIRCUIT ANALYSIS REVEALED THAT DIODE ARRAY D84, A COMPONENT OF THE ¿ALARM OUT¿ CIRCUITRY, HAD AN ATYPICAL VOLTAGE OUTPUT. A SHORT BETWEEN PIN 1 AND PIN 3 WAS OBSERVED. THE COMPONENT WAS REPLACED, AND THE CONTROLLER WAS RECONNECTED TO A MOCK CIRCULATORY LOOP. THE ATYPICAL POWER MODULE ALARM WAS UNABLE TO BE REPRODUCED. FOLLOWING THE REPAIR, THE SYSTEM CONTROLLER UNDERWENT FUNCTIONAL TESTING AND PASSED WITHOUT ISSUE. A ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE A DAMAGED COMPONENT ON THE MAIN PCB OF (B)(6). A MANUFACTURING TASK WAS OPENED TO INVESTIGATE THE DIODE ISSUE. A POTENTIAL ROOT CAUSE WAS DETERMINED TO BE MATERIAL; HOWEVER, IT IS INCONCLUSIVE HOW THE CONTROL MAIN PCB HAD AN ISSUE POST MANUFACTURING AND TESTING AT SUPPLIER AND ABBOTT MCS. AN EXTERNAL CORRECTIVE ACTION REQUEST (ECAR) WAS CREATED TO INFORM THE SUPPLIER OF THIS EVENT. HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION 8 - ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 - ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO DEVICE IMPLANTATION, A LOUD CONTINUOUS BEEP WAS HEARD FROM THE POWER MODULE (PM), BUT AN ALARM WAS NOT HEARD FROM THE CONTROLLER. THE HEARTMATE TOUCH (HMT) SHOWED NO ADDTIONAL ALARMS AND HTE EXTENDED SILENCE WAS STILL ACTIVE. THE SILENCE ALARM ON THE PM WAS PRESSED AND APPROXIMATELY 5 MINUTES LATER THE ALARM RETURNED. THE PM WAS REPLACED. THIS SECOND PM ALSO ALARMED AFTER 5 MINUTES WITHOUT ANY ALARMS FROM THE CONTROLLER AND THE HMT STILL SHOWED THE EXTENDED SILENCE STILL BEING ACTIVATED. THE FIRST PM (PPM-27270 WITH PATIENT CABLE M239410321) ALARM AGAIN AND EVERY 5 MINUTES AFTERWARD. ONCE AGAIN NO NEW ALARMS APPEARED ON THE CONTROLLER OR HMT DURING THE ALARM TONE. AT THIS POINT, A THIRD PM AND PATIENT CABLE SYSTEM WAS OBTAINED (PPM-29553 AND PATIENT CABLE L/N M284580122) AND CONNECTED TO CONTROLLER (B)(6). ONCE THE HMT (DMPX305FHP83 AND ADAPTER 003055) WERE RE-PAIRED VIA BLUETOOTH, THE EXTENDED SILENCE WAS ENGAGED FROM THE HMT WITHOUT PRESSING ANY SILENCE BUTTONS ON ANY PIECE OF EQUIPMENT PRIOR TO THIS EXTENDED SILENCE. AFTER DISCUSSIONS WITH TECH SERVICES, THE DECISION WAS MADE TO REPLACE CONTROLLER (B)(6). THE MODULAR CABLE (LOT 8446898) WAS DISCONNECTED FROM THIS CONTROLLER. A NEW CONTROLLER (HSC-122139) WAS OPENED ONTO THE STERILE FIELD, AND THE PATIENT CABLE (L/N M284580122) CONNECTED TO PPM-29553 WERE CONNECTED TO THIS CONTROLLER. NO SILENCE BUTTONS WERE PRESSED ON THE CONTROLLER OR POWER MODULE AND THE EXTENDED SILENCE WAS SUBSEQUENTLY ACTIVATED FROM THE HMT S/NDMPX305FHP83 AND ADAPTER 003055. NO FURTHER ALARMS WERE HEARD OR OBSERVED BEYOND THE TYPICAL ALARMS AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658467 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8763335 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male