BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO COMPACTFLO EVOLUTION OXYGENATOR

    MDR report key: 5370716 · Received January 15, 2016

    Report

    Report Number
    9680841-2015-00676
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 7, 2015
    Report Date
    December 18, 2015
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED DEVICE IS NOT DISTRIBUTED IN USA, BUT IT IS SIMILAR TO THE APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DEVICE, WHICH IS DISTRIBUTED IN THE USA (510K #: K092895). ALTHOUGH THE COMPLAINED DEVICE IS AVAILABLE, THERE IS NO NEED FOR DEVICE INVESTIGATION SINCE THE ISSUE (BLOOD TO WATER LEAK) IS KNOWN AND A CAPA PROJECT (007/08) HAS BEEN COMPLETED. SORIN GROUP (B)(4) MANUFACTURES THE DIDECO COMPACTFLO EVOLUTION OXYGENATOR. THE INCIDENT OCCURED IN (B)(6). (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT BLOOD LEAKED INTO WATER LINES OF THE HEAT EXCHANGER OF THE DIDECO COMPACTFLO EVOLUTION OXYGENATOR. THIS WAS DISCOVERED 30 MINUTES INTO THE PROCEDURE. THE CIRCUIT WAS CHANGED IN LESS THEN 3 MINUTES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. THE COMPLAINED DEVICE WAS NOT RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THIS IS A KNOWN ISSUE CAUSED BY CORROSION IN AREAS WITH METAL, WHICH ARE STRESSED BY MANUFACTURING PROCESSES. A CAPA PROJECT ((B)(4)) WAS COMPLETED IN APRIL 2015 TO REDUCE THE OCCURRENCE OF SIMILAR DEFECTS. THE HEAT EXCHANGER LOT OF THE COMPLAINED UNIT WAS ASSEMBLED BEFORE IMPLEMENTATION OF THE CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT BLOOD LEAKED INTO WATER LINES OF THE HEAT EXCHANGER OF THE DIDECO COMPACTFLO EVOLUTION OXYGENATOR. THIS WAS DISCOVERED 30 MINUTES INTO THE PROCEDURE. THE CIRCUIT WAS CHANGED IN LESS THEN 3 MINUTES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29457 DIDECO COMPACTFLO EVOLUTION OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1503100154

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR