BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 6427788 · Received March 23, 2017

    Report

    Report Number
    3007042319-2017-00819
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    October 26, 2016
    Report Date
    February 24, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION: EITHER TWO BATTERIES, OR ONE BATTERY AND AN AC ADAPTER OR DC ADAPTER. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. THEY ALSO OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER TO PREVENT DAMAGES. IT IS OUTLINED TO INSPECT THE POWER CONNECTIONS AND PINS ONCE A WEEK, ONE AT A TIME WHEN CHANGING THE POWER SOURCE. ADDITIONALLY, THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. THE DEVICE LABELING WARNS THAT DISCONNECTING BOTH POWER SOURCES (BATTERIES AND AC OR DC ADAPTER) AT THE SAME TIME WILL STOP THE PUMP. AT LEAST ONE POWER SOURCE MUST BE CONNECTED ALWAYS. THE IFU FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED ADDITIONAL DEVICES FOR THIS COMPLAINT: (B)(4)- CATALOG-1650DE, EXP DATE - 2015-10-31, MFR NUMBER- 2014-10-22, UDI NUMBER- (B)(4), RETURN DATE -02-27-2017; (B)(4)- CATA LOG-1650DE, EXP DATE - 2015-10-31, MFR NUMBER- 2014-10-22, UDI NUMBER- (B)(4), RETURN DATE -02-27-2017; (B)(4)- CATA LOG-1650DE, EXP DATE - 2015-10-31, MFR NUMBER- 2014-10-23, RETURN DATE -02-27-2017; (B)(4)- CATA LOG-1650DE, EXP DATE - 2015-10-31, MFR NUMBER- 2014-10-10, UDI NUMBER- (B)(4), RETURN DATE -02-27-2017; (B)(4)- CATA LOG-1650DE, EXP DATE - 2015-10-31, MFR NUMBER- 2014-10-22, UDI NUMBER-(B)(4), RETURN DATE -02-27-2017; (B)(4)- CATA LOG-1650DE, EXP DATE - 2016-09-30, MFR NUMBER- 2015-09-10 , RETURN DATE -02-27-2017. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED FROM THE SITE THAT THE BATTERY OF THE LEFT VENTRICULAR SUPPORT DEVICE CONTROL UNIT FAILED TWICE IN SUCCESSION DESPITE BEING FULLY CHANGED AND HAVING A GOOD CONNECTION. NO ADDITIONAL INFORMATION AVAILABLE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING EVENTS. ONE CONTROLLER AND SIX BATTERIES 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. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED OCCURRENCES OF PREMATURE POWER SWITCHING EVENTS PRIOR TO BATTERIES REACHING THE 25% RELATIVE STATE OF CHARGE (RSOC) THRESHOLD. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER ((B)(4)) REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPEN TO EVALUATE THE MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND THE BATTERIES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT WAS HAVING POWER SWITCHING. IT WAS STATED THAT THE PATIENT HAD NO EFFECT AND WAS DOING FINE. A CONTROLLER EXCHANGE WAS PERFORMED AND THE BATTERIES WERE ALSO TAKEN OUT OF SERVICE AND REPLACED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209828 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1