BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 6788711 · Received August 11, 2017

    Report

    Report Number
    3007042319-2017-02604
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    July 14, 2017
    Report Date
    October 2, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CONTROLLER (B)(4) FAILED EXTERNAL VISUAL INSPECTION AND PASSED FUNCTIONAL TESTING. ADDITIONAL DETAILS OF THE INVESTIGATION WILL BE PROVIDED IN A FINAL REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE, WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE CONTROLLER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF CONTROLLER UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACK AROUND POWER PORT 1 AND 2. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS WERE NOT RELATED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION CONDUCTED, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. LOG FILE ANALYSIS CONFIRMED ONE (1) CONTROLLER FAULT ALARM ON (B)(6) 2017, INDICATING A FAULT REGARDING THE INTERNAL BATTERY THAT POW ERS THE ¿NO POWER¿ ALARM. CONTROLLER 2.0 HAS A FEATURE THAT MONITORS THE INTERNAL BATTERY¿S VOLTAGE AND WILL ALERT THE USER IF A FAULT WAS DETECTED BY TRIGGERING A CONTROLLER FAULT ALARM. A REVIEW OF THE LOGS REVEALED THAT THE CONTROLLER FAULT WAS DUE TO THE INTERNAL BATTERY EXCEEDING 3.75V. HOWEVER, THE MAXIMUM VOLTAGE OF THE BATTERY WILL NOT REACH THE 3.75V THRESHOLD, INDICATING THAT THE FAULT IS MOST LIKELY RELATED TO THE MONITORING PORTION OF THE CIRCUIT. FURTHER ANALYSIS REVEALED THAT A RESISTOR IN THE MONITORING CIRCUIT WAS EXHIBITING ERRATIC ELECTRICAL BEHAVIOR. THIS FINDING DOES NOT AFFECT THE ABILITY OF THE INTERNAL BATTERY TO POWER THE ¿NO POWER¿ ALARM. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO A FAULTY RESISTOR IN THE INTERNAL BATTERY¿S MONITORING CIRCUIT. AN INTERNAL INVESTIGATION WAS OPENED TO INVESTIGATE FAULTY RESISTORS IN THE CONTROLLER'S INTERNAL BATTERY MONITORING CIRCUIT THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE CONTROLLER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED HAIRLINE CRACKS AROUND POWER PORT ONE (1) AND POWER PORT TWO (2). THIS OBSERVATION IS NOT RELATED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION WAS OPENED TO EVALUATE CRACKS OBSERVED ON PIONEER 2.0, IN THE AREA SURROUNDING THE POWER PORT CONNECTORS. LOG FILE ANALYSIS CONFIRMED ONE (1) CONTROLLER FAULT ALARM ON (B)(6) 2017, INDICATING A FAULT REGARDING THE INTERNAL BATTERY THAT POWERS THE ¿NO POWER¿ ALARM. CONTROLLER 2.0 HAS A FEATURE THAT MONITORS THE INTERNAL BATTERY¿S VOLTAGE AND WILL ALERT THE USER IF A FAULT WAS DETECTED BY TRIGGING A CONTROLLER FAULT ALARM. A REVIEW OF THE LOGS REVEALED THAT THE CONTROLLER FAULT WAS DUE TO THE INTERNAL BATTERY EXCEEDING 3.75V. HOWEVER, THE MAXIMUM VOLTAGE OF THE BATTERY WILL NOT REACH THE 3.75V THRESHOLD, INDICATING THAT THE FAULT IS MOST LIKELY RELATED TO THE MONITORING PORTION OF THE CIRCUIT. FURTHER ANALYSIS REVEALED THAT A RES ISTOR IN THE MONITORING CIRCUIT WAS EXHIBITING ERRATIC ELECTRICAL BEHAVIOR. THIS FINDING DOES NOT AFFECT THE ABILITY OF THE INTERNAL BATTERY TO POWER THE ¿NO POWER¿ ALARM. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO A FAULTY RESISTOR IN THE INTERNAL BATTERY¿S MONITORING CIRCUIT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CONTROLLER EXCHANGE. ONCE THEY SWITCHED TO THE NEW ONE, A CONTROLLER FAULT ALARM OCCURRED. THAT CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569540 HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR