BEUDAMED
    FDA Adverse Event Other Summary report: N

    D100 DIDECO KIDS

    MDR report key: 2482493 · Received February 29, 2012

    Report

    Report Number
    1718850-2012-00014
    Event Type
    Other
    Date Received
    February 29, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 30, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K061031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D100 KIDS OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT TWO HOURS INTO BYPASS, THE OXYGENATOR WAS NOT OXYGENATING WELL DURING BYPASS. ANESTHESIA HAD TO ASSIST THE PT BY VENTILATION. THERE WAS NO REPORT OF PT INJURY. SORIN GROUP (B)(4) HAS REQUESTED THE PRODUCT BE RETURNED FOR EVAL. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT TWO HOURS INTO BYPASS, THE OXYGENATOR WAS NOT OXYGENATING WELL DURING BYPASS. ANESTHESIA HAD TO ASSIST THE PT BY VENTILATION. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D100 DIDECO KIDS HOLLOW FIBER MEMBRANE OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR DTZ SORIN GROUP ITALIA NA 1110040089

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO