BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5245661 · Received November 24, 2015

    Report

    Report Number
    3007042319-2015-03134
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    November 5, 2015
    Report Date
    November 5, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PUMPS, (B)(4), AND TWO CONTROLLERS, (B)(4), WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE LOG FILE ANALYSIS DID NOT REVEAL ANY ANOMALIES DURING THE ANALYZED PERIOD. LOG FILES DID REVEAL AN INCREASE IN USAGE OF A CONTROLLER AC ADAPTER ON (B)(6) 2015. HOWEVER, NO ABNORMALITIES WERE OBSERVED FOR ANY OF THE BATTERIES IN USE BY THE PATIENT ON BOTH CONTROLLERS. BASED ON LOG FILE ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON LOG FILE ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: PUMP: (B)(4) - EXPIRATION DATE: 03-31-20216. (B)(4). PUMP: (B)(4) - EXPIRATION DATE: 03-31-20216. (B)(4). THIS IS ONE OF TWO REPORTS (3007042319-2015-03134, 3007042319-2015-03135) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE INFORMATION ON DO NOT PLUG THE CONTROLLER INTO AN AC WALL OUTLET DURING SHOWERS; TO ELIMINATE THE POSSIBILITY OF A SEVERE ELECTRICAL SHOCK, IT SHOULD BE CONNECTED TO TWO BATTERIES. ALSO NEVER CLEAN THE MONITOR WITH THE POWER ON, AS THIS MAY LEAD TO AN ELECTRICAL SHOCK. DO NOT USE ALCOHOL OR DETERGENT ON THE MONITOR DISPLAY. GENTLY WIPE THE DISPLAY WITH A SOFT, LINT FREE CLOTH. MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC) AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THIS USER MANUAL. PORTABLE AND MOBILE RADIO FREQUENCY (RF) COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. IT IS FURTHER STATED TO NOT UNDERGO PROCEDURES REQUIRING HIGH POWER ELECTRICAL TREATMENT (E.G. APPLICATION OF DIATHERMY) WHILE THE PUMP IS IMPLANTED. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. THE IFU WARNS THAT IF THERE IS A CONTROLLER FAILURE, THE CONTROLLER SHOULD BE SWITCHED TO THE BACK-UP CONTROLLER. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. LOG FILE ANALYSIS FOR REVIEW DATE: 11/06/2015: DATED THROUGH (B)(6) 2015: NORMAL POWER CONSUMPTION. ADDITIONAL NOTES: NO ALARMS HAVE BEEN LOGGED IN THE LAST 14 DAYS OF AVAILABLE DATA. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2015-03134, 3007042319-2015-03135) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS STATED THAT THE AICD HAD NOT BEEN INTERROGATED. IT WAS ALSO STATED THAT PATIENT ONLY USES BATTERIES FOR HIS LVAD'S DUE TO THE STATEMENTS HE HAS MADE OF BEING SHOCKED. PATIENT HAS STATED THAT HE HAS BEEN SHOCKED SEVERAL TIMES BUT HAS NOT BEEN COMFORTABLE WITH TRYING TO ISOLATE THE ISSUE. PATIENT DESCRIBES THE SHOCKS AS UNCOMFORTABLE, AND STATES HE FEELS THEM COMING. PATIENT WAS SAID TO HAVE BEEN DISCHARGED ON (B)(6) 2015 ON IV ANTIBIOTICS UNTIL (B)(6) 2015. REPEAT BLOOD CULTURES HAVE BEEN ALL NEGATIVE THUS FAR. NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING IMPLANT DATE - (B)(6) 2014. THIS IS ONE OF TWO REPORTS (3007042319-2015-03134, 3007042319-2015-03135) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE CONTROLLER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA FUNCTIONAL TESTING. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION BUT FAILED FUNCTIONAL TESTING DUE TO CONTINUOUS RESETTING WHILE CONNECTED TO POWER. IT WAS ALSO NOTED THAT NO ALARMS WERE ISSUED WHEN ALL SOURCES WERE DISCONNECTED. FURTHER INSPECTION REVEALED THAT THE INTERNAL BATTERY WAS NON-FUNCTIONAL. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A FAULTY UIC, AN INTERNAL COMPONENT OF THE CONTROLLER. 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 BY THE SITE THAT THE PATIENT WHO IS A BI-VAD PATIENT, REPORTS BEING SHOCKED MULTIPLE TIMES IN THE PAST WHEN CONNECTED TO WALL POWER. PATIENT COMPLAINS THAT WHEN HE'S PLUGGED IN TO AC POWER, HE GETS SHOCKED THAT RUN DOWN HIS BODY. HE EVEN REPORTS HE HAS HAD SOME "SHOCK BURNS ON HIS TOES." HE CLAIMS THIS HAS HAPPENED AT MULTIPLE LOCATIONS, NOT JUST AT HOME AND INCLUDING THE HOSPITAL. HE REPORTS THAT THIS HAS NOT HAPPENED WHILE CONNECTED TO DC POWER (BATTERIES OR IN CAR). WHEN HE WAS UNDER CARE AT ANOTHER HOSPITAL, HE WAS SET UP WITH AN ISOLATION TRANSFORMER THAT SEEMED TO RELIEVE THE SHOCKS. WHEN PATIENT TRANSITIONED TO NEW SITE, THEY DID THE SAME, THEY PLUGGED HIM INTO AC POWER ONLY WITH AN ISOLATION TRANSFORMER. HE HAS NOT HAD INSTANCES OF SHOCKS IN THE THREE TIMES HE HAS BEEN AN INPATIENT AT NEW SITE. AT HOME PATIENT REPORTS HE EXCLUSIVELY USES BATTERIES TO AVOID SHOCKS. IT WAS STATED THAT THE LOG FILES WERE SENT AND REVIEWED. SITE SPOKE WITH MANUFACTURER CLINICAL ENGINEERING AND HE STATED THIS COULD BE POSSIBLE IF PATIENTS AICD LEADS ARE LOCATED CLOSE TO THE PUMP. RECOMMENDATION FROM CLINICAL ENGINEERING WAS TO INTERROGATE THE AICD WHILE CONNECTED TO BATTERIES AND THEN INTERROGATE CONNECTED TO WALL POWER AND SEE IF THERE WAS ANY INTERFERENCE WHILE ON WALL POWER. LEAD PLACEMENT FOR AICD MAY NEED TO BE ADJUSTED, AS PER MANUFACTURER CLINICAL ENGINEER. NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778315 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R