BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 3120011 · Received May 20, 2013

    Report

    Report Number
    3007042319-2013-00081
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 19, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014, Z-1917-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE RETURNED TO HEARTWARE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF HVAD PUMP (B)(4) IN RELATION TO THE REPORTED EVENT. THESE INCLUDED LABELING/INSTRUCTIONS FOR USE, CLINICAL EVALUATION, LOG REVIEW/ANALYSIS AND REVIEW OF MANUFACTURING DOCUMENTATION. THE CONTROLLER AND FOUR BATTERIES WERE RETURNED TO HEARTWARE FOR TESTING AND EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT ALL DEVICES MET SPECIFICATIONS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES CONFIRM VAD STOPS AND CRITICAL BATTERY ALARMS RELEVANT TO THE REPORTED EVENT, WHICH IS CONSISTENT WITH THE REPORTERS CLAIM OF A HIGH PRIORITY ALARM. THE CONTROLLER AND (B)(4) PASSED VISUAL AND FUNCTIONAL TESTING. (B)(4) ALL FAILED FUNCTIONAL TESTING. INTERNAL EVALUATION DETERMINED THAT EACH OF THE THREE BATTERIES HAD BROKEN WIRES ON THE DATA COMMUNICATION LINE WITHIN THE BATTERY CABLE CONNECTORS. ADDITIONALLY, TESTING OF THE THREE PROBLEM BATTERIES ((B)(4)) REVEALED A CONDITION INDICATIVE OF A DEFECTIVE CELL THAT COULD CAUSE AN IMBALANCE AND MAY PRODUCE AN OUT OF SPECIFICATION BATTERY CALIBRATION ERROR. OF NOTE, ALL BATTERIES HAD BETWEEN 200 AND 300 CHARGE/DISCHARGE CYCLES AND HAD BEEN IN USE FOR BETWEEN 2 YEARS ((B)(4) SHIPPED TO SITE (B)(4) 2011) AND 3 YEARS ((B)(4) SHIPPED TO SITE (B)(4) 2010). DURING TESTING OF THE THREE AFFECTED BATTERIES WITH THE COMPLAINT CONTROLLER, THE VAD STOP CONDITION WAS REPLICATED AS NOTED IN THE LOG FILE REVIEW WHEN USING TWO FAULTY BATTERIES. THE COMPLAINT IS CONFIRMED FOR "CRITICAL BATTERY" ALARMS AND "POOR CONNECTION" VIA THE LOG FILES AND ADDITIONAL TESTING. THIS WAS DUE TO BROKEN DATA WIRES WITHIN THE BATTERY CONNECTORS FOUND ON THREE OF THE COMPLAINT BATTERIES. THIS WOULD INTERRUPT THE BATTERY'S COMMUNICATION WITH THE CONTROLLER, WHICH WOULD CAUSE THE CONTROLLER TO SWITCH OVER TO THE OTHER POWER SOURCE. ADDITIONALLY, TESTING WAS ABLE TO REPLICATE A VAD STOP CONDITION AS NOTED IN THE CONTROLLER ALARM LOG FILE USING THE AFFECTED BATTERIES WITH THE CONTROLLER. THE EXACT CAUSE OF THE BROKEN WIRES CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, LONG TERM USE OF THE BATTERY IS NOTED. THIS IS ONE OF THREE REPORTS (3007042319-2013-00079, 3007042319-2013-00080 AND 3007042319-2013-00081) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. SITE REPORTED THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER WAS CONSTANTLY CHANGING BETWEEN POWER SOURCES AS OBSERVED BY THE VAD COORDINATOR DURING A ROUTINE CLINIC VISIT. THERE WAS NO REPORTED PATIENT INJURY RELATED TO THIS EVENT. THE BATTERIES WERE EXCHANGED BY THE FACILITY AND RETURNED TO THE MANUFACTURER. THE CONTROLLER ((B)(4)) PASSED ALL VISUAL AND FUNCTIONAL TESTING. HOWEVER, REVIEW OF CONTROLLER LOG FILES REVEALED TWO CRITICAL BATTERY ALARMS THEREFORE CONFIRMING THE REPORTED EVENT. THE BATTERY ((B)(4)) REVEALED INTERNAL WIRE DAMAGE. THE ROOT CAUSE OF REPORTED EVENT CAN BE ATTRIBUTED TO A COMBINATION OF COMMUNICATION MALFUNCTIONS BETWEEN THE CONTROLLER AND THE BATTERIES, FAULTY INTERNAL CELLS WITHIN THE BATTERY PACK AND BATTERY WIRE DAMAGE. BASED ON THE RESULTS OF THE PREVIOUS MANUFACTURER'S INTERNAL INVESTIGATION, FIELD ACTIONS AND CHANGES TO THE BATTERY INTERNAL CELL SUPPLIER, NO ADDITIONAL INVESTIGATION OF THIS EVENT IS REQUIRED AT THIS TIME. THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO FAULTY INTERNAL CELLS WITHIN THE BATTERY PACK. FIELD SAFETY NOTICE (FSCA APR2014) WAS ISSUED TO PROVIDE PATIENTS AND HEALTHCARE PROVIDERS WITH INFORMATION TO RECOGNIZE BATTERIES WITH LESS THAN TWO HOURS OF RUN TIME, AS WELL AS REEMPHASIZE INSTRUCTION ON ACTIONS TO TAKE WHEN BATTERY ALARMS OCCUR AND REINFORCE PROPER POWER MANAGEMENT. FIELD SAFETY NOTICE WAS THEN EXPANDED (FSCA APR2014.1) IN ORDER TO REMOVE BATTERIES FROM THE FIELD THAT WERE RELEASED PRIOR TO THE IMPLEMENTATION OF ENHANCED BATTERY SCREENING PROCESS TO ADDRESS AND PREVENT BATTERY FAILURES. A FIELD SAFETY NOTICE (FSCA APR2015A) WAS ISSUED TO CLINICIANS TO BE DELIVERED TO PATIENTS CURRENTLY ON DEVICE. IT PROVIDED AWARENESS, WARNINGS, AND SAFETY MITIGATIONS REGARDING POTENTIAL COMMUNICATION ISSUES BETWEEN THE CONTROLLER AND BATTERY POWER SOURCES. 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, INCLUDING TRANSPORTATION. THE INSTRUCTIONS FOR USE (IFU), PATIENT MANUAL, AND TRAINING MATERIAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF POWER SOURCES. THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, VISUAL AND AUDIBLE ALARM MANAGEMENT, AND DEVICE MANAGEMENT; ADDITIONAL GUIDELINES INSTRUCT THE USER ON HOW TO DETECT AND REACT TO A POWER SOURCE MALFUNCTION. 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI); THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OR THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS IS FIVE OF FIVE REPORTS (3007042319-2013-00079, 2013-00080, 2013-00081, 3007042319-2015-03380 AND 3007042319-2015-03381) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY TWENTY-NINE MONTHS AFTER THE IMPLANTATION, THE PATIENT¿S DAUGHTER CALLED THE VAD COORDINATOR TO REPORT THAT HER FATHER¿S CONTROLLER HAD A HIGH PRIORITY ALARM WHILE SHE WAS TRYING TO CHANGE OUT A NEARLY DEPLETED BATTERY. THE PATIENT WAS RESTING AT THE TIME OF THE EVENT. ACCORDING TO THE DAUGHTER, (B)(4) WAS IN USE AT THE TIME OF THE EVENT WITH (B)(4) IN PLACE IN PORT 1 AND (B)(4) IN PLACE IN PORT 2; WITH PORT 1 ACTUALLY POWERING THE CONTROLLER. THE DAUGHTER REPORTED THAT (B)(4)'S CAPACITY HAD APPROXIMATELY 30% CHARGE (PORT 1) WHEN THE CONTROLLER SWITCHED TO PORT 2 WITHOUT AN AUDIBLE ALARM. WHEN THE BATTERY IN PORT 2 HAD BEEN DEPLETED, THE PATIENT¿S DAUGHTER ATTEMPTED TO EXCHANGE IT WITH A FULL ONE. AT SOME POINT THE CRITICAL BATTERY ALARM SOUNDED. THE DAUGHTER IS REPORTED TO HAVE THEN CONNECTED PORT 1 TO AC POWER AND TO HAVE REPLACED DEPLETED BATTERY IN PORT 2 WITH A BATTERY THAT HAD A 70% CAPACITY. THE DAUGHTER THEN DISCONNECTED THE AC ADAPTER (IN ORDER TO CONNECT A FULLY CHARGED BATTERY) AND A HIGH PRIORITY ALARM OCCURRED AGAIN. THE VAD COORDINATOR REPORTED THAT THEY WERE ABLE TO REPRODUCE THE BATTERY SWITCHING EVENT WITH (B)(4) AND ALSO NOTED THAT THE CONTROLLER WAS SWITCHING POWER SOURCES WHEN (B)(4) WAS INDICATING A 50% CAPACITY. SINCE THE VAD COORDINATOR COULD NOT CONFIRM CONCLUSIVELY WHICH BATTERIES HAD BEEN IN USE AT THE TIME OF THE EVENT, THEY OPTED TO EXCHANGE THE PATIENT¿S CONTROLLER AND ALL FOUR OF HIS BATTERIES. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE SITE HAS INDICATED THAT IT WILL BE RETURNING ALL OF THE EXCHANGED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221954 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER - (B)(4)