BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOOD SAM CINCINNATI OH 1

    MDR report key: 1316261 · Received December 11, 2008

    Report

    Report Number
    1718850-2008-00033
    Event Type
    Malfunction
    Date Received
    December 11, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 14, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APEX OXYGENATOR IS MFG BY: SORIN GROUP. THE 510(K) # FOR THE APEX OXYGENATOR IS K014080. THE APEX OXYGENATOR, MFG BY SORIN GROUP IS A COMPONENT IN THE PERFUSION PACK MFG BY SORIN GROUP USA INC. THE PERFUSION PACK IS A PREAMENDMENT DEVICE. ONE APEX OXYGENATOR WAS RECEIVED AT SORIN GROUP USA FOR EVALUATION. A VISUAL INSPECTION OF THE DEVICE SHOWED NO DEFECTS. BOTH THE WATER AND BLOOD SIDE OF THE OXYGENATOR WERE PRESSURE TESTED WITH WATER AND DID NOT PRODUCE ANY LEAKS. THE WATERSIDE OF THE DEVICE WAS PRESSURIZED WITH WATER OVER TIME AND NO DEGRADATION IN PRESSURE WAS SEEN. THE REPORTED LEAK COULD NOT BE DUPLICATED. THE APEX OXYGENATOR HAS BEEN RETURNED TO SORIN GROUP FOR FURTHER EVALUATION. A F/U REPORT WILL BE FILED WITH THEIR FINDINGS.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT THERE WAS A PINK TINGE IN THE HEATER/COOLER WATER LINES PRIOR TO COOLING THE PT. THE HEATER/COOLER HAD NOT BEEN TURNED ON AND WATER HAD NOT RECIRCULATED THROUGH THE OXYGENATOR. THE UNIT WAS REPLACED. THERE WAS NO PT INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOOD SAM CINCINNATI OH 1 CUSTOM PERFUSION PK DWE SORIN GROUP USA, INC. NA 0823800171

    Patients

    Seq Age Sex Outcome Treatment
    1