BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP87641 GB SOUTHAMPTON

    MDR report key: 1644540 · Received March 22, 2010

    Report

    Report Number
    1718850-2010-00019
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 19, 2010
    Report Date
    February 19, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWE
    PMA / PMN Number
    K061031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED AT (B)(6) HOSPITAL, (B)(6). SORIN GROUP (B)(4) MANUFACTURES THE D100 OXYGENATOR. SORIN GROUP USA IS FILING THIS REPORT ON BEHALF OF SORIN GROUP (B)(4). THE D100 OXYGENATOR IS APPROVED FOR DISTRIBUTION IN THE US. THE 510(K) NUMBER FOR THE D100 IS K061031. THE PATIENT WAS ADMITTED TO THE HOSPITAL IN A CARDIAC ARREST STATE. THE PATIENT RECEIVED CARDIOPULMONARY RESUSCITATION, DIAGNOSIS AND THEN SURGERY. DURING BYPASS, THE PERFUSIONIST REPORTED DIFFICULTY IN MAINTAINING GAS TRANSFER. BLOOD FLOW WAS 600-700 ML/MINUTE AND GAS FLOW WAS 3 LITERS/MINUTE. THE OXYGENATOR WAS NOT CHANGED OUT DUE TO THE PATIENT'S CONDITION. DESCRIBED AS VERY POOR AND HYPOXIC. NO LEAKS WERE EVIDENT, NO ISSUES WITH PRESSURE DROP AND NO OTHER OBVIOUS CLINICAL ISSUES WERE PRESENT. PATIENT DID NOT COME OFF BYPASS AND WAS TRANSFERRED TO INTENSIVE CARE ON ECMO, SHOWING PRIMARY PULMONARY FAILURE. THE OXYGENATOR WILL BE MADE AVAILABLE FOR INVESTIGATION. UPON RECEIPT, A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL IN A CARDIAC ARREST STATE. THE PATIENT RECEIVED CARDIOPULMONARY RESUSCITATION, DIAGNOSIS AND THEN SURGERY. DURING BYPASS, THE PERFUSIONIST REPORTED DIFFICULTY IN MAINTAINING GAS TRANSFER. BLOOD FLOW WAS 600-700 ML/MINUTE AND GAS FLOW WAS 3 LITERS/MINUTE. THE OXYGENATOR WAS NOT CHANGED OUT DUE TO THE PATIENT'S CONDITION, DESCRIBED AS VERY POOR AND HYPOXIC. NO LEAKS WERE EVIDENT, NO ISSUES WITH PRESSURE DROP AND NO OTHER OBVIOUS CLINICAL ISSUES WERE PRESENT. PATIENT DID NOT COME OFF BYPASS AND WAS TRANSFERRED TO INTENSIVE CARE ON ECMO, SHOWING PRIMARY PULMONARY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP87641 GB SOUTHAMPTON PERFUSION TUBING SYSTEM DWE SORIN GROUP ITALIA NA 0905180273

    Patients

    Seq Age Sex Outcome Treatment
    1