BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT SYSTEM

    MDR report key: 5014344 · Received August 13, 2015

    Report

    Report Number
    9611109-2015-00297
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    December 1, 2015
    Report Date
    February 22, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K002118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP DEUTSCHLAND MANUFACTURES THE COMPACT SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP DEUTSCHLAND. SORIN GROUP DEUTSCHLAND RECEIVED A REPORT THAT THE SC SYSTEM REPEATEDLY HAD DAMAGE OCCURRING TO THE CAK & SAL BOARDS & SHUNT RESISTOR APPROXIMATELY FOUR MONTHS AFTER EACH REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE COMPACT SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED FAILURE AND OBSERVED AN ERROR CODE DURING TESTING. THE FAILURE WAS TRACED TO A DEFECTIVE (B)(4) BOARD AND SHUNT RESISTOR. BOTH PARTS WERE REPLACED TO RESOLVE THE ISSUE AND SUBSEQUENT TESTING OF THE DEVICE DID NOT IDENTIFY ANY FURTHER ISSUES. THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE. EVALUATED ON SITE BY LIVANOVA TECHNICIAN.

    Description of Event or Problem · 1

    SORIN GROUP DEUTSCHLAND RECEIVED A REPORT THAT THE SC SYSTEM REPEATEDLY HAD DAMAGE OCCURRING TO THE CAK & SAL BOARDS & SHUNT RESISTOR APPROXIMATELY FOUR MONTHS AFTER EACH REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532689 COMPACT SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND GMBH 55-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA