BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6225174 · Received January 5, 2017

    Report

    Report Number
    3007042319-2017-00028
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 7, 2016
    Report Date
    October 5, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-0005-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES INVOLVED IN THIS EVENT: BATTERY/(B)(4); CAT# 1650DE; EXP DATE:09/30/2015; MFG. DATE: 09/30/2014; BATTERY ISSUE; DATE RECEIVED:12/20/2016. BATTERY/(B)(4); CAT# 1650DE; EXP DATE:04/30/2017; MFG. DATE: 04/30/2016; BATTERY ISSUE; DATE RECEIVED:12/20/2016. BATTERY/(B)(4); CAT# 1650DE; EXP DATE:02/29/2016; MFG. DATE: 02/29/2015; BATTERY ISSUE; DATE RECEIVED:12/20/2016. BATTERY/(B)(4); CAT# 1650DE; EXP DATE:11/30/2016; MFG. DATE: 11/30/2015; BATTERY ISSUE; DATE RECEIVED:12/20/2016. BATTERY/(B)(4); CAT# 1650DE; EXP DATE:09/30/2015; MFG. DATE: 09/30/2014; BATTERY ISSUE; DATE RECEIVED:12/20/2016. BATTERY/(B)(4); CAT# 1650DE; EXP DATE:09/30/2015; MFG. DATE: 09/30/2014; BATTERY ISSUE; DATE RECEIVED:12/20/2016. 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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE INFORMATION AND OUTLINES THE STEPS TO KEEP SPARE, FULLY CHARGED BATTERIES AND CONTROLLERS AVAILABLE AT ALL TIMES. ALSO STATED IN IFU IS THAT THE SYSTEM HAS MULTIPLE POWER SOURCES AVAILABLE (AC ADAPTER, DC ADAPTER, AND BATTERIES). THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) - AN INTERNAL INVESTIGATION HAS BEEN OPENED BY THE SUPPLIER TO ADDRESS LOOSE CONNECTORS. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS AND THAT THE CONTROLLER LED INDICATORS WERE MALFUNCTIONING. THE CONTROLLER AND SIX BATTERIES WERE 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 BATTERIES REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE UNITS PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE CONTROLLER REVEALED THAT THE UNIT PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION DUE TO A LOOSE POWER PORT ONE (1) CONNECTOR. A POSSIBLE ROOT CAUSE OF THE LOOSE CONNECTOR MAY BE ATTRIBUTED TO A SHIFT IN THE MANUFACTURING PROCESS. THE LOOSE CONNECTOR FINDING IS NOT RELATED TO THE REPORTED EVENT. THE REPORTED CONTROLLER LED MALFUNCTION COULD NOT BE CONFIRMED OR REPLICATED DURING TESTING. THE LED DISPLAY WAS TESTED WITH BATTERIES AT DIFFERENT CHARGE LEVELS AND ALL THE LED LIGHTS WORKED AS INTENDED. SUPPLEMENTAL TESTING WAS PERFORMED, WHICH VERIFIED THAT THE INTERNAL CIRCUITRY ASSOCIATED WITH THE LEDS WERE OPERATING AS EXPECTED. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO A COMMUNICATION ERROR CAUSED BY AN EXTERNAL INTERFERENCE ON THE CONTROLLER AT THE TIME OF THE REPORTED EVENT. THE REPORTED EVENT (POWER SWITCHING) WAS CONFIRMED VIA LOG FILES. A REVIEW OF THE DATA LOG FILE REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTS INVOLVING (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE SWITCHING CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND LOSS OF COMMUNICATION BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSE OF THE CONTROLLER'S LED INDICATORS MALFUNCTIONING MAY BE ATTRIBUTED TO A COMMUNICATION ERROR CAUSED BY AN EXTERNAL INTERFERENCE ON THE CONTROLLER AT THE TIME OF THE REPORTED EVENT. THE LED INDICATORS, HOWEVER, OPERATED AS EXPECTED WHEN TESTED. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO ADDRESS MOMENTARY DISCONNECTIONS. (B)(4) - BATTERY. UDI #: (B)(4). MFR DATE: 09-29-2014. METHOD: VISUAL INSPECTION; ANALYSIS OF DATA LOG(S); INTEROPERABILITY EVALUATION; ACTUAL DEVICE EVALUATED. RESULT: INTEROPERABILITY PROBLEM. CONCLUSION: QUALITY SYSTEM DEFICIENCY. (B)(6) - BATTERY. UDI #: (B)(4). MFR DATE: 04-14-2016. METHOD: VISUAL INSPECTION; ANALYSIS OF DATA LOG(S); INTEROPERABILITY EVALUATION; ACTUAL DEVICE EVALUATED. RESULT: INTEROPERABILITY PROBLEM. CONCLUSION: QUALITY SYSTEM DEFICIENCY. (B)(4) - BATTERY. UDI #: (B)(4). MFR DATE: 02-26-2015. METHOD: VISUAL INSPECTION; ANALYSIS OF DATA LOG(S); INTEROPERABILITY EVALUATION; ACTUAL DEVICE EVALUATED. RESULT: INTEROPERABILITY PROBLEM. CONCLUSION: QUALITY SYSTEM DEFICIENCY. (B)(4) - BATTERY UDI #: (B)(4). MFR DATE: 11-25-2015. METHOD: VISUAL INSPECTION; ANALYSIS OF DATA LOG(S); INTEROPERABILITY EVALUATION; ACTUAL DEVICE EVALUATED. RESULT: INTEROPERABILITY PROBLEM. CONCLUSION: QUALITY SYSTEM DEFICIENCY. (B)(4) - BATTERY. (B)(4). MFR DATE: 09-29-2014. METHOD: VISUAL INSPECTION; ANALYSIS OF DATA LOG(S); INTEROPERABILITY EVALUATION; ACTUAL DEVICE EVALUATED. RESULT: INTEROPERABILITY PROBLEM. CONCLUSION: QUALITY SYSTEM DEFICIENCY. (B)(4) - BATTERY. UDI #: (B)(4). MFR DATE: 09-27-2014. METHOD: VISUAL INSPECTION; ANALYSIS OF DATA LOG(S); INTEROPERABILITY EVALUATION; ACTUAL DEVICE EVALUATED. RESULT: INTEROPERABILITY PROBLEM. CONCLUSION: QUALITY SYSTEM DEFICIENCY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE BY THE VAD COORDINATOR THAT HER BATTERIES ARE NOT CORRECTLY ACCEPTED BY THE CONTROLLER. BATTERY POWER SWITCHES FROM PORT EARLIER THAN EXPECTED. THE VAD COORDINATOR TOOK A LOOK AT THE CONTROLLER DURING PATIENT VISIT AND NOTED ADDITIONALLY A MALFUNCTION OF THE BATTERY LED OF THE CONTROLLER. PICTURE WAS TAKEN AND SEND TOGETHER WITH LOG FILES FOR ANALYSIS. IT WAS STATED THAT THE LOG FILE ANALYSIS SHOWED POTENTIAL BATTERY SWITCHING AND IT WAS ADVISED TO EXCHANGE ALL AFFECTED BATTERIES AND THE CONTROLLER. AN ELECTIVE CONTROLLER EXCHANGE WAS PERFORMED AND SIX BATTERIES WERE ALSO EXCHANGED AND IT WAS STATED THAT THERE WERE NO CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9489 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1