BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX HP M ADULST HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 3012074 · Received March 13, 2013

    Report

    Report Number
    1718850-2013-00045
    Event Type
    Other
    Date Received
    March 13, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K092895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF ON SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THERE WAS REDUCED BLOOD FLOW THROUGH THE OXYGENATOR MODULE DURING A CASE. THE OXYGENATOR WAS CHANGED OUT AND THE CASE CONTINUED. THERE WAS NO PATIENT INJURY. THE HOSPITAL REPORTED THAT THE DEVICE WAS DISCARDED AND UNAVAILABLE FOR RETURN. WITHOUT PRODUCT RETURN FOR EVALUATION, ROOT CAUSE COULD NOT BE INVESTIGATED. HOWEVER, THIS TYPE OF INCIDENT IS CONSISTENT WITH PLATELET ACTIVATION AND INCREASING CLOTTING OVER TIME BY MICRO AGGREGATES. IT APPEARS THAT THE PHENOMENON MAY BE LINKED TO PATIENT HEMATOLOGICAL CONDITIONS, AS WELL AS SURGICAL-PHARMACEUTICAL CONDITIONS. EPISODES OF EXTREME HEMOSTASIS CAN OCCUR DUE TO BIOLOGICAL EVENTS RELATED TO THE PATIENT, MEDICATIONS AND/OR SURGICAL CONTRIBUTIONS EXPERIENCED DURING SURGERY. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR THIS ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THERE WAS REDUCED BLOOD FLOW THROUGH THE OXYGENATOR MODULE DURING A CASE. THE OXYGENATOR WAS CHANGED OUT AND THE CASE CONTINUED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106212 APEX HP M ADULST HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1210310023

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR