BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 4187579 · Received October 2, 2014

    Report

    Report Number
    1718850-2014-00352
    Event Type
    Other
    Date Received
    October 2, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K092895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE RETURNED APEX OXYGENATOR WAS VISUALLY INSPECTED AND NO EVIDENCE OF ANY DEFECT WAS PRESENT. LEAK TESTING WAS PERFORMED BY PRESSURIZING THE WATER SIDE AND BLOOD SIDE OF THE OXYGENATOR HEAT EXCHANGER. DURING PRESSURIZED TESTING, NO LEAKS WERE OBSERVED. SORIN GROUP (B)(4) HAS CONCLUDED THE CAUSE OF THE WATER NOTED BY THE CUSTOMER MAY BE RELATED TO THE MANNER IN WHICH THE CUSTOMER PRESSURIZED THE OXYGENATOR AND THEN REMOVED THE WATER LINES. WATER COULD HAVE BEEN LEFT IN THE OXYGENATOR'S HEAT EXCHANGER AND THUS, THE REASON THE RESIDUAL WATER ON THE TOWEL PLACED UNDER THE OXYGENATOR BY THE CUSTOMER AFTER THE WATER LINES WERE REMOVED AND NOTED. THE REPORTED ISSUE WAS NOT CONFIRMED. TESTING SHOWED NO LEAKS OR ISSUES WITH THE OXYGENATOR HEAT EXCHANGER. SORIN GROUP (B)(4) WILL BE MONITOR THIS ISSUE FOR TRENDS AND CORRECTIVE ACTION WILL BE RECOMMENDED IF TRENDS ARE IDENTIFIED.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING PRE-OP TESTING OF THE APEX OXYGENATOR, FLUID WAS SEEN LEAKING FROM THE HEAT EXCHANGER. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613992 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OCYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1403250006

    Patients

    Seq Age Sex Outcome Treatment
    1