BEUDAMED
    FDA Adverse Event Other Summary report: N

    D101 DIDECO KIDS

    MDR report key: 2550737 · Received April 18, 2012

    Report

    Report Number
    1718850-2012-00030
    Event Type
    Other
    Date Received
    April 18, 2012
    Date of Event
    February 9, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K072091
    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 D101 DIDECO KIDS. 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 OF POOR OXYGENATION FROM A D101 KIDS OXYGENATOR. ALTHOUGH THERE WAS NO REPORT OF PATIENT INJURY RESULTING FROM THIS EVENT, IT WAS LATER REPORTED THAT THE PATIENT WAS VENTILATED TO ALLEVIATE ANY RISK OF HARM RESULTING FROM THE OXYGENATION PROBLEMS. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. THE INVOLVED DEVICE WAS NOT AVAILABLE FOR EVALUATION BY SORIN GROUP (B)(4). HOWEVER, THE PUMP RECORDS FROM THE CASE WERE PROVIDED. SORIN GROUP (B)(4) REVIEWED THE RECORDS AND FOUND THAT ALTHOUGH THE SWEEP RATE AND FIO2 WERE HIGH DURING CROSS CLAMP, THE PO2 LEVELS WERE GOOD. A SLIGHT DROP IN GAS EXCHANGE PERFORMANCE WAS NOTED TOWARDS THE END OF THE PROCEDURE DURING REWARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE UNIT. WITHOUT THE INVOLVED DEVICE FOR EVALUATION THE ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED. SORIN GROUP (B)(4) HAS DETERMINED THAT THIS IS A VERY RARE OCCURRENCE AND NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF POOR OXYGENATION FROM A D101 KIDS OXYGENATOR. THERE WAS NO REPORT OF PATIENT INJURY RESULTING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D101 DIDECO KIDS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1012210062

    Patients

    Seq Age Sex Outcome Treatment
    1 NP