BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3760330 · Received April 20, 2014

    Report

    Report Number
    3007042319-2014-00375
    Event Type
    Malfunction
    Date Received
    April 20, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 21, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1917-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, CON182208 PASSED VISUAL INSPECTION AND FUNCTIONAL TEST WITHOUT ANY PROBLEM. REVIEW OF THE LOG FILES SHOWED CRITICAL BATTERY ALARMS AS REPORTED COMPLAINT. THERE WERE EVIDENCES IN THE LOG WHICH SHOWED THAT THE CONTROLLER DIDN'T DECODE THE BATTERY CAPACITY CORRECTLY WHEN THE DATA WAS TRANSFERRED FROM THE BATTERY TO CONTROLLER. HOWEVER, THE CRITICAL BATTERY ALARM COULDN'T BE REPRODUCED DURING FUNCTIONAL TEST WHEN THE TESTING THE RETURNED CONTROLLER WITH TEST-BED BATTERY. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH INAPPROPRIATE "CRITICAL BATTERY" ALARMS ARE MOST OFTEN ATTRIBUTED TO CORRUPT COMMUNICATION BETWEEN THE BATTERY AND CONTROLLER. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED CRITICAL BATTERY ALARMS. THERE WAS NO REPORTED PATIENT INJURY RELATED TO THIS EVENT. THE CONTROLLER AND BATTERIES WERE TAKEN OUT OF USE AND NEW EQUIPMENT WAS ISSUED TO THE PATIENT. THE CONTROLLER AND BATTERIES WERE RETURNED TO THE MANUFACTURER AND EVALUATED. THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. REVIEW OF THE LOG FILES SHOWED CRITICAL BATTERY ALARMS AS REPORTED COMPLAINT ALONG WITH TWO DOUBLE POWER DISCONNECTS ON REPORTED EVENT DATE. BOTH BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTS. THE MOSTLY LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. FIELD SAFETY NOTIFICATION, FSCA APR2015A, HAS BEEN TAKEN TO NOTIFY USERS OF THIS ISSUE. A FOLLOW-UP FIELD ACTION WILL BE TAKEN TO IMPLEMENT THE SOFTWARE CHANGE PER PROJECT #(B)(4) HVAD PIONEER SMR (SOFTWARE MAINTENANCE RELEASE). 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. 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 ONE OF THREE REPORTS (3007042319-2014, 00375, 2015-04145 AND 3007042319-2015-04146) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    APPROXIMATELY SIX MONTHS POST IMPLANTATION, THE SITE REPORTED THAT THE PATIENT HAD EXPERIENCED CRITICAL BATTERY ALARMS. THE BATTERIES AND CONTROLLER WERE REMOVED FROM THE PATIENT AND NEW BATTERIES AND CONTROLLER WERE SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. PRELIMINARY REVIEW OF THE LOG FILES REVEALED THAT THE PATIENT HAD EXPERIENCED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239147 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - BATTERY| (B)(4) - BATTERY