BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENROSE HSP CO SPRINGS CO 1

    MDR report key: 933608 · Received April 4, 2007

    Report

    Report Number
    1718850-2007-00006
    Event Type
    Malfunction
    Date Received
    April 4, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 9, 2007
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WOULD NOT PROVIDE THIS INFORMATION. THE CUSTOM PERFUSION PACK IS MADE BY SORIN GROUP USA, INC. THE SERIAL NUMBER IS FOR THE PRIMO2X OXYGENATOR MANUFACTURED BY SORIN GROUP, A SORIN GROUP COMPANY. IT IS DISTRIBUTED BY SORIN GROUP, AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER FOR THE SORIN GROUP PRIMO2X IS K050447. THE PRIMO2X OXYGENATOR IS A COMPONENT IN THE CUSTOM PERFUSION PACK. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 088111900, IS A PRE-AMENDMENT DEVICE. A STATIC LEAK TEST CONFIRMED A SMALL BLOOD TO WATER LEAK IN THE PRIMO2X OXYGENATOR HEAT EXCHANGER. THE PRIMO2X OXYGENATOR WAS RETURNED TO SORIN GROUP ITALIA FOR EVALUATION OF THE FAILURE MODE. A FOLLOW UP REPORT WILL BE FILED WITH THIS INFORMATION.

    Description of Event or Problem · 1

    AT THE END OF BYPASS, WHILE RINSING THE HEATER/COOLER, IT WAS NOTICED THAT THE HEATER/COOLER WATER HAD A PINK TINGE TO IT. THIS SUGGESTED THAT A MINOR BLOOD TO WATER LEAK FROM THE OXYGENATOR HEAT EXCHANGER HAD OCCURRED. ALL BLOOD GASES & PATIENT PRESSURES WERE GOOD THROUGHOUT THE CASE. THE PATIENT'S RECOVERY WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENROSE HSP CO SPRINGS CO 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 0632400111

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR