BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 11992057 · Received June 14, 2021

    Report

    Report Number
    3007042319-2021-03927
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 4, 2021
    Report Date
    August 30, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000475
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. ADDITIONAL PRODUCTS: SERIAL# (B)(6), H6: IMG CODE(S):G0403401 H6:FDA METHOD CODE(S): : B15, B17 H6:FDA RESULT CODE(S): C04 H6:FDA CONCLUSION CODE(S): D02 SERIAL# (B)(6), H6: IMG CODE(S):G0403401 H6:FDA METHOD CODE(S): : B15, B17 H6:FDA RESULT CODE(S): C04 H6:FDA CONCLUSION CODE(S): D02 SERIAL# (B)(6), H6: IMG CODE(S):G0403401 H6:FDA METHOD CODE(S): : B15, B17 H6:FDA RESULT CODE(S): C04 H6:FDA CONCLUSION CODE(S): D02 SERIAL# (B)(6), H6: IMG CODE(S):G0403401 H6:FDA METHOD CODE(S): : B15, B17 H6:FDA RESULT CODE(S): C04 H6:FDA CONCLUSION CODE(S): D02 SERIAL# (B)(6), H6: IMG CODE(S):G0403401 H6:FDA METHOD CODE(S): : B15, B17 H6:FDA RESULT CODE(S): C04 H6:FDA CONCLUSION CODE(S): D02 SERIAL# (B)(6), H6: IMG CODE(S):G0403401 H6:FDA METHOD CODE(S): : B15, B17 H6:FDA RESULT CODE(S): C04 H6:FDA CONCLUSION CODE(S): D02 PRODUCT EVENT SUMMARY: THE CONTROLLER ((B)(6)) WAS RETURNED FOR EVALUATION. SIX (6) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. VISUAL INSPECTION OF THE CONTROLLER REVEALED CONTAMINATION WITHIN BOTH POWER PORTS, THUS CONFIRMING THE REPORTED FOREIGN MATERIAL EVENT. ADDITIONALLY, A VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK AROUND POWER PORT ONE (1). AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK IS NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00381374, THE ROOT CAUSE OF THE HAIRLINE CRACK 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. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALLS WITHIN THE BOUNDS OF THIS CAPA. DURING FUNCTIONAL TESTING, POWER SOURCES WERE ABLE TO SECURELY CONNECT TO BOTH CONTROLLER POWER PORTS. AS A RESULT, THE REPORTED POOR MECHANICAL CONNECTION EVENT COULD NOT BE CONFIRMED. SUPPLEMENTAL TESTING WAS PERFORMED ON THE CONTROLLER AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6), AS WELL AS SEVERAL MOMENTARY DISCONNECTIONS THAT DID NOT LEAD TO PREMATURE POWER SWITCHING EVENTS INVOLVING (B)(6). MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE OR ¿BEEP.¿ ADDITIONALLY, ANALYSIS OF THE DATA LOG FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO COMMUNICATION ERRORS INVOLVING (B)(6). REVIEW OF THE DATA LOG FILE ALSO REVEALED MULTIPLE ADDITIONAL INSTANCES INVOLVING (B)(6) WHERE THE BATTERIES' RELATIVE STATE OF CHARGE (RSOC) WAS LOGGED AS A VALUE BETWEEN 101 AND 201, WHICH IS INDICATIVE OF COMMUNICATION ERRORS.. ANALYSIS OF THE ALARM LOG FILE REVEALED 63 CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING (B)(6), LOGGED BETWEEN (B)(6) 2021 AND (B)(6) 2021. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILE DID NOT REVEAL ANY POWER DISCONNECT ALARMS RECORDED WITHIN THE ANALYZED PERIOD; HOWEVER, IT IS LIKELY THAT THE OBSERVED COMMUNICATION ERRORS ARE ASSOCIATED WITH THE REPORTED POWER DISCONNECT ALARMS. REVIEW OF THE EVENT LOG FILE REVEALED NINE (9) CONTROLLER POWER UP EVENTS, WITH ASSOCIATED MOTOR START EVENTS, LOGGED BETWEEN (B)(6) 2021 AND (B)(6) 2021. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE OF 17 SECONDS. SEVERAL MOMENTARY DISCONNECTIONS WERE RECORDED LEADING UP TO MULTIPLE LOSSES OF POWER. AS A RESULT, THE REPORTED PREMATURE POWER SWITCHING, BEEPING, POWER PORT CONTAMINATION, CRITICAL BATTERY ALARMS, AND CONTROLLER LOSS OF POWER EVENTS WERE CONFIRMED. THE REPORTED POWER DISCONNECT ALARMS EVENT COULD NOT BE CONFIRMED, BUT LIKELY CORRESPOND WITH THE OBSERVED COMMUNICATION ERRORS. THE ASSOCIATED POWER SOURCES HAD BEEN LUBRICATED PRIOR TO RELEASE. THE MOST LIKELY ROOT CAUSE OF THE CONTAMINATION WITHIN THE CONTROLLER POWER PORTS CAN BE ATTRIBUTE, BUT NOT LIMITED, TO THE HANDLING OF THE DEVICE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS, LIKELY DUE TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS, AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. HOWEVER, THE MOST LIKELY ROOT CAUSE OF THE "REPORTED BEEPS" CAN MOST LIKELY BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARMS AND POWER DISCONNECTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. POSSIBLE ROOT CAUSES OF THE COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERIES, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 30-SEP-2020 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 12-SEP-2019, LABELED FOR SINGLE USE: NO. (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER EXHIBITED POWER SWITCHING ASSOCIATED WITH MULTIPLE RANDOM BEEPS DAILY WHILE THE PATIENT WAS WALKING AROUND. THE POWER SOURCES DID NOT FEEL SECURE ON POWER PORT ONE OF THE CONTROLLER, AND THE POWER SOURCES SOMETIMES ONLY PROVIDED POWER TO THE CONTROLLER WHEN THE POWER SOURCE CONNECTORS WERE PUSHED AND HELD IN PLACE. IT WAS NOTED THAT POWER PORT ONE OF THE CONTROLLER HAD GREEN AND WHITE MATERIAL INSIDE THE PORT. THERE WERE MULTIPLE UNEXPECTED LOSSES OF POWER TO THE CONTROLLER, SIX BATTERIES WERE ASSOCIATED WITH MULTIPLE POWER DISCONNECT ALARMS, AND FIVE OF THE BATTERIES WERE ASSOCIATED WITH ERRONEOUS CRITICAL BATTERY ALARMS. THE CONTROLLER WAS EXCHANGED AND THE BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890240 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000475

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 1103 VAD