BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAKELAND REG LAKELAND FL 1

    MDR report key: 1676090 · Received May 3, 2010

    Report

    Report Number
    1718850-2010-00094
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 16, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURERS THE APEX OXYGENATOR. THE 510(K) NUMBER IS K083021. THE DEVICE IS A COMPONENT OF THE SORIN GROUP USA CUSTOM PERFUSION PACK (B)(4). THIS REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). DURING THE PROCEDURE, THE PERFUSIONIST REPORTED EXPERIENCING LOW PO2 VALUES. THE APEX OXYGENATOR WAS CHANGED OUT. THERE WAS NO PATIENT INJURY. RISK MANAGEMENT STATED THAT A VOLUNTARY REPORT UNDER MEDICAL RECORD (B)(4) WAS FILED AS "PRODUCT USE ERROR" AND NOT A MALFUNCTION. IT WAS ALSO STATED THAT THE BIOMED, ANESTHESIA, AND PERFUSIONIST INDICATED THE OXYGENATOR DID NOT APPEAR TO BE CLOGGED. RISK MANAGEMENT INDICATED THAT THE DEVICE WAS INADVERTENTLY DISCARDED AND NOT AVAILABLE FOR EVALUATION. WITHOUT THE PHYSICAL DEVICE, IT IS NOT POSSIBLE TO EVALUATE THE REPORTED PROBLEM. HOWEVER, AS A RESULT OF THE FACILITY'S ASSESSMENT AS STATED ABOVE, IT APPEARS THAT THE DEVICE FUNCTIONED PROPERLY AND THE POTENTIAL PROBLEM WAS USER ERROR. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PERFUSIONIST REPORTED EXPERIENCING LOW PO2 VALUES. THE DEVICE WAS CHANGED OUT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAKELAND REG LAKELAND FL 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1001300026

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR