BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 3012719 · Received March 20, 2013

    Report

    Report Number
    3007042319-2013-00022
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1323-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS VISUALLY CONFIRMED IN THE FIELD AND WAS ADDRESSED BY THE SITE PERSONNEL. NO FURTHER ACTION IS REQUIRED. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: APPROXIMATELY SIX WEEKS AFTER INITIAL EVENT, THE REAR PART OF THE CONNECTOR WAS LOOSE AGAIN AND THE PATIENT RETURNED TO THE HOSPITAL; HE WAS ANXIOUS. THE HEARTWARE CLINICAL ENGINEER PERFORM A SUCCESSFUL DRIVELINE CONNECTOR REPAIR. THE PATIENT WAS DISCHARGED WITH NO REPORTED INJURY. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    DRIVELINE CABLE,(B)(4), WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DRIVELINE CABLE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE LOG FILES DID NOT REVEAL ANY ALARMS AROUND THE EVENT DATE OF (B)(6) 2013 THROUGH (B)(6) 2013. ON-SITE INSPECTION OF THE DRIVELINE CABLE REVEALED THAT THE BACK NUT OF THE CONNECTOR WAS LOOSE; THUS CONFIRMING THE REPORTED EVENT. A DRIVELINE CONNECTOR REPAIR WAS PERFORMED TO MITIGATE THE CONDITIONS REPORTED. HEARTWARE HAD INITIATED AN INTERNAL INVESTIGATION TO EVALUATE ISSUES RELATED TO LOOSENING OF THE DRIVELINE CONNECTOR. BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE OF THE LOOSE CONNECTOR MAY BE ATTRIBUTED TO THE INTERACTION OF RTV SILICONE AND EPOXY DURING THE CONNECTOR ASSEMBLY PROCESS THAT CAUSES A REDUCTION IN BONDING STRENGTH. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    APPROXIMATELY 13 MONTHS POST HEARTWARE LVAD IMPLANTATION, DURING THE EXAMINATION OF THE DRIVELINE CABLE FOR THIS PATIENT, THE CONNECTOR WAS FOUND TO BE LOOSE (REAR PORTION). THIS FINDING WAS IDENTIFIED AS A RESULT OF THE TECHNICAL BULLETIN (3007042319-01/18/13-001-C ) ISSUED ON 18/01/2013 BY HEARTWARE INC. FOR THIS MATTER. THE DRIVELINE CABLE CONNECTOR COULD NOT BE COMPLETELY UNSCREWED AND REMOVED, SO THE SITE PERSONNEL FULLY TIGHTENED THE CONNECTOR WITH A WRENCH. THE SITE DISCUSSED THE ISSUE WITH HEARTWARE PERSONNEL AND IT WAS DETERMINED THAT NO FURTHER ACTION WAS REQUIRED. THE EVENT WAS RESOLVED WITHOUT PATIENT INJURY. THE SITE WILL CONTINUE TO MONITOR THE PATIENT'S DRIVELINE CABLE CONNECTOR DURING ROUTINE VISITS AND WILL CONSULT WITH HEARTWARE IF FURTHER ACTION IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116361 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM, DRIVELINE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1