BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 18610625 · Received January 30, 2024

    Report

    Report Number
    2916596-2024-00495
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 10, 2024
    Report Date
    May 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER BEING EXCHANGED DUE TO HIGH PATIENT POWER AND FLOW VALUES BEING OBSERVED WAS CONFIRMED. THE PROVIDED LOG FILES FROM THE CONTROLLER COLLECTIVELY CONTAINED DATA SPANNING APPROXIMATELY 28 DAYS (19DEC2023 ¿ 16JAN2024 PER TIMESTAMP), AND THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. THE PATIENT¿S POWER AND FLOW VALUES WERE INTERMITTENTLY OBSERVED TO INCREASE TO HIGHER VALUES THROUGHOUT THE DATA. THE CONTROLLER WAS EXCHANGED ON 18JAN2024 DUE TO THE INTERMITTENT POWER FLUCTUATIONS. LOG FILES FROM THE PATIENT¿S NEW CONTROLLER WERE PROVIDED AND SHOWED CONTINUED INTERMITTENT POWER AND FLOW ELEVATIONS THROUGHOUT THE DATA. THE SYSTEM CONTROLLER (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. PER ADDITIONAL INFORMATION, THE POWER AND FLOW ELEVATIONS EVENTUALLY RESOLVED ON THEIR OWN AND WAS NOT RELATED TO AN EQUIPMENT ISSUE. THE ROOT CAUSE FOR THE REPORTED POWER ELEVATIONS WAS UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS AND COULD NOT BE CORRELATED TO AN ISSUE WITH THE EXCHANGED SYSTEM CONTROLLER. THE HEARTMATE II PATIENT HANDBOOK (REV. C, SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR, INCLUDING THE POWER CABLE DISCONNECT ALARM. THE HEARTMATE II PATIENT HANDBOOK (REV. C, SECTION TITLED ¿EMERGENCY CONTACT LIST¿) 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT URGENT LOG FILE REVIEW WAS REQUESTED FOR CONCERN FOR PUMP THROMBUS DUE TO HIGH WATTS AND HIGH FLOWS. THE LOG FILE CAPTURED A SHIFT IN PUMP POWERS EARLY ON (B)(6) 2024. BASELINE POWERS WERE 4-5W AND HAD SINCE BEEN CONSTANTLY IN THE 8-9 W RANGE. IT WAS ALSO NOTED THAT THERE WERE MORE FREQUENT PULSATILITY INDEX (PI) EVENTS. TECHNICAL SERVICES NOTED THAT THE GRAPH SHOWS AN INCREASE IN PUMP POWERS WITH A DECREASE IN THE PI VALUES AND NOTED THAT THOSE TYPES OF TRENDS WERE TYPICALLY INDICATIVE OF A POTENTIAL THROMBUS CONCERN. MORE LOG FILES WERE SUBMITTED ON (B)(6) 2024, AND THERE WERE SEVERAL POWER/FLOW ELEVATIONS THROUGHOUT THE EVENT HISTORY. THE PATIENT WAS NOT SYMPTOMATIC, AND THEIR LABS WERE ALL WITHIN NORMAL LIMITS. IT WAS COMMUNICATED ON (B)(6) 2024 THAT THE LOG FILE CAPTURED SOME ELEVATED PUMP POWERS THROUGHOUT THE LOG WITH POWER NOTED AS HIGH AS 9.6W. THE MAJORITY OF THESE ELEVATED POWERS WERE ASSOCIATED WITH PI EVENTS. TECHNICAL SERVICES NOTED THAT IN LOOKING AT THE GRAPH TRENDS, IT LOOKED LIKE POWERS WERE TRENDING DOWN ALMOST 2W WITH PI VALUES TRENDING UP. IT WAS NOTED THAT A SYSTEM CONTROLLER EXCHANGE WAS PERFORMED ON 18JAN2024 UNDER SURGICAL DIRECTOR¿S ADVICE DUE TO THE PATIENT HAVING NO CLINICAL SIGNS OF THROMBUS. LOG FILE REVIEW WAS REQUESTED AND DID NOT CAPTURE TOO MANY DATA POINTS POST CONTROLLER EXCHANGE ON 18JAN2024 AT 1421. THERE WAS ABOUT 4 HOURS' WORTH OF DATA. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) (PUMP)

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PUMP PARAMETERS CAPTURED 2 UNSUSTAINED, ISOLATED POWER ELEVATIONS. THE OVERALL TRENDING WAS UNREMARKABLE. IT WAS ADDITIONALLY REPORTED THAT THE CONTROLLER WAS EXCHANGED DUE TO THE ELEVATED POWER/FLOW VALUES, AND THAT THE EXCHANGE APPEARED TO HELP THE ISSUE. THERE WAS NO ONGOING TREATMENT AS THE ISSUE APPEARED TO RESOLVE ON ITS OWN. NO PRODUCTS WERE TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108925 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male