BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIDS D100 NEONATAL OXYGENATOR

    MDR report key: 1247243 · Received October 2, 2008

    Report

    Report Number
    1718850-2008-00029
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K061031
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND MEDWATCH REPORT ON THIS SAME INCIDENT WAS RECEIVED FROM THE FDA ON 9/29/08. THE MEDWATCH REPORT STATED THAT THE BLOOD FLOW RATE DECREASED, PUMP PRESSURES WERE LOW AND THE PT STARTED TO DECLINE. THE OXYGENATOR WAS CHANGED OUT AND THE PT'S ARTERIAL PRESSURES IMMEDIATELY INCREASED. THE HOSP PT SAFETY SPECIALIST WAS CONTACTED BY SORIN GROUP USA, INC. THE SPECIALIST WOULD NOT PROVIDE SORIN GROUP USA, INC. WITH ANY INFO ON THE EVENT OR THE PT. A REQUEST WAS MADE TO RETURN THE D100 OXYGENATOR TO SORIN GROUP USA, INC. FOR EVAL. THE SPECIALIST STATED THAT THE PRODUCT WAS NOT AVAILABLE. WITHOUT PRODUCT, THE CAUSE OF THE REPORTED DEFECT CAN NOT BE DETERMINED. HOWEVER, DURING A CONVERSATION WITH THE PERFUSIONIST IN 2008, HE INDICATED THAT HE DID NOT FEEL THE OXYGENATOR WAS AT FAULT BUT THAT THE INCIDENT MAY HAVE BEEN CAUSED BY THE ADDITION OF BANK BLOOD TO THE CIRCUIT. SORIN GROUP USA, INC DISTRIBUTES THE KIDS D100 OXYGENATOR. SORIN GROUP MANUFACTURES THE D100 OXYGENATOR. THEY HAVE BEEN NOTIFIED OF THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIDS D100 NEONATAL OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1