BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 12796860 · Received November 11, 2021

    Report

    Report Number
    3007042319-2021-07992
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Report Date
    January 19, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: ONE CONTROLLER (B)(6) AND SIX BATTERIES (B)(6) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF(B)(6) REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. AS RECEIVED, (B)(6) WAS COMPLETELY DEPLETED. FUNCTIONAL TESTING REVEALED THAT A CELL-UNDER-VOLTAGE (CUV) AND PACK-UNDER-VOLTAGE (PUV) FLAGS WERE ENABLED. HOWEVER, THE BATTERY WAS ABLE TO ADEQUATELY CHARGE DURING BENCH TESTING. AFTER ALLOWING THE BATTERY TO CHARGE THE CUV AND PUV FLAGS WERE RESET, AND THE BATTERY PERFORMED AS INTENDED. FAILURE ANALYSIS OF (B)(6) REVEALED THAT THE BATTERY PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF (B)(6) REVEALED A TEAR ON THE OUTER SHEATH OF THE CABLE ASSEMBLY; THE OBSERVED DAMAGE DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DAMAGE TO THE BATTERY CABLE ASSEMBLY EVENT CAN BE ATTRIBUTED TO WEAR AND/OR THE HANDLING OF THE DEVICE. CAPA: PR00405633 IS INVESTIGATING DAMAGE TO POWER SOURCES. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH POWER PORTS AND THE PUMP CONNECTOR. ADDITIONALLY, VISUAL INSPECTION REVEALED SCRATCHES ON THE CONTROLLER'S LIQUID CRYSTAL DISPLAY (LCD) ON THE FRONT PANEL WINDOW. THE OBSERVED DAMAGE DID NOT ALLOW CLEAR VISIBILITY OF THE DISPLAY PARAMETERS. THE OBSERVED CONTAMINATION WITHIN THE PUMP CONNECTOR AND SCRATCHES ON THE CONTROLLER DISPLAY ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED SCRATCHES ON THE CONTROLLER DISPLAY EVENT CAN BE ATTRIBUTED TO THE HANDLING OF THE DEVICE. 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 FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A 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 THAT (B)(6) WERE NOT IN USE WITHIN THE ANALYZED PERIOD. REVIEW OF THE EVENT LOG FILE ALSO REVEALED TWO CONTROLLER POWER-UPS WITH ASSOCIATED PUMP START EVENTS LOGGED ON (B)(6) 2021 AT 10:57:52 AND 10:58:08. THE DATA POINT PRIOR TO THE LOSSES OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE WITH 95% RSOC AND THAT (B)(6) WAS CONNECTED TO POWER PORT TWO WITH 44% RSOC. THE DATA POINT RECORDED AFTER THE LOSSES OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT AND (B)(6) WAS CONNECTED TO POWER PORT TWO. NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR A TOTAL OF TWENTY-FOUR SECONDS. THE OBSERVED LOSSES OF POWER EVENT IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. A POSSIBLE ROOT CAUSE OF THE OBSERVED 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. CAPA: PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. ANALYSIS OF THE DATA LOG FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND ADDITIONAL BATTERIES. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. ADDITIONALLY, REVIEW OF THE ALARM LOG FILE REVEALED A CRITICAL BATTERY ALARM WAS RECORDED ON (B)(6) 2021 AT 22:54:08 DUE TO A COMMUNICATION ERROR INVOLVING AN ADDITIONAL BATTERY. REVIEW OF THE DATA LOG FILE ALSO REVEALED MULTIPLE INSTANCES INVOLVING ADDITIONAL BATTERIES WHERE THE BATTERIES' RELATIVE STATE OF CHARGE (RSOC) VALUES WERE LOGGED BETWEEN 101-201, WHICH ARE INDICATIVE OF COMMUNICATION ERRORS. THE ADDITIONAL BATTERIES WERE LUBRICATED PRIOR TO RELEASE. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON THE BATTERY(B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 15-OCT-2019. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON THE BATTERIES (B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 09-JUL-2019. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON THE BATTERIES (B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 06-DEC-2019. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON THE BATTERY (B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 21-AUG-2019. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONTAMINATION WITHIN THE CONTROLLER PORTS CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES, AND TO MOMENTARY DISCONNECTIONS, WHICH MAY BE ATTRIBUTED TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. POSSIBLE ROOT CAUSES OF THE COMMUNICATION ERRORS CAN BE ATTRIBUTED TO A MOMENTARY DISCONNECTION 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. ADDITIONAL PRODUCTS: D4: (B)(6); D9: YES, RETURN DATE: 16-NOV-2021; H3: YES DEV RTN TO MFR? YES; H6: IMG CODE(S): G02004 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C07 H6: FDA CONCLUSION CODE(S): D11 D4: (B)(6); D9: YES, RETURN DATE: 16-NOV-2021; H3: YES DEV RTN TO MFR? YES; H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: (B)(6); D9: YES, RETURN DATE: 16-NOV-2021; H3: YES DEV RTN TO MFR? YES; H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14; D4: (B)(6); D9: YES, RETURN DATE: 16-NOV-2021; H3: YES DEV RTN TO MFR? YES; H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14; D4: (B)(6); D9: YES, RETURN DATE: 16-NOV-2021; H3: YES DEV RTN TO MFR? YES; H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14; D4: (B)(6); D9: YES, RETURN DATE: 16-NOV-2021; H3: YES DEV RTN TO MFR? YES; H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2019 / 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: 26-DEC-2018. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2019 / 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: 10-OCT-2018. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2019 / 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: 10-OCT-2018. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-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: 19-OCT-2019. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2019 / 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: 07-DEC-2018. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-JULY-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: 31-JUL-2019. LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROLLER AND BATTERIES EXHIBITED POWER SWITCHING. THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695599 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 1104 VAD.