BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC ASHLAND KY 1

    MDR report key: 2470786 · Received February 8, 2012

    Report

    Report Number
    1718850-2012-00005
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 9, 2012
    Manufacturer
    SORIN GROUP USA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR WHICH IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER FOR THE PRIMO2X OXYGENATOR IS K050447. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WATER WAS FOUND IN THE ARTERIAL LINE AND CENTRIFUGAL PUMP AFTER SETTING UP THE CIRCUIT AND PRESSURIZING THE WATER LINES TO CHECK FOR LEAKS. THE CIRCUIT HAD BEEN LEFT SITTING FOR APPROX 48 HOURS. THIS OCCURRED DURING SET-UP. THERE WAS NO PT INVOLVEMENT. THE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN FOR EVAL. VISUAL INSP FOUND NO DEFECTS OR ABNORMALITIES RELATED TO THE REPORTED ISSUE. LEAK TESTING CONFIRMED COMMUNICATION BETWEEN THE WATER SIDE AND BLOOD SIDE COMPARTMENTS. THE OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER ANALYSIS. THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. SORIN GROUP (B)(4) HAS IMPLEMENTED A FIELD ACTION REGARDING THIS ISSUE. THE PERFUSIONIST HAS BEEN CONTACTED THROUGH THE FIELD ACTION NOTIFICATION. THE Z NUMBER IS PENDING AND WILL BE SUBMITTED WHEN AVAILABLE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT WATER WAS FOUND IN THE ARTERIAL LINE AND CENTRIFUGAL PUMP AFTER SETTING UP THE CIRCUIT AND PRESSURIZING THE WATER LINES TO CHECK FOR LEAKS. THE CIRCUIT HAD BEEN LEFT SITTING FOR APPROX 48 HOURS. THIS OCCURRED DURING SET-UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC ASHLAND KY 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA NA 1130000059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA