BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINE MED PORTLAND ME 1

    MDR report key: 2617467 · Received June 6, 2012

    Report

    Report Number
    1718850-2012-00063
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    May 6, 2012
    Report Date
    May 7, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR AND THE 510(K) NUMBER IS K050447. THE OXYGENATOR IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP USA RECEIVED A REPORT THAT WHILE USING THE PRIMO2X OXYGENATOR DURING A PROCEDURE, THE CLINICIAN NOTICED BLOOD IN THE WATER LINE. THE OXYGENATOR WAS CHANGED OUT AND THE CASE CONTINUED WITHOUT FURTHER ISSUES. IT WAS STATED THAT THERE WAS BLOOD IN THE PT'S URINE WHEN COMING INTO THE OPERATING ROOM BUT THAT THIS CONDITION HAD IMPROVED BY THE END OF THE CASE. THERE WAS NO REPORT OF PT INJURY DUE TO THIS EVENT. THE OXYGENATOR WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. TESTING OF THE UNIT FOUND A LEAK PATH BETWEEN THE BLOOD SIDE AND WATER SIDE OF THE HEAT EXCHANGE, CONFIRMING THE REPORTED ISSUE. THE OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT WHILE USING THE PRIMO2X OXYGENATOR DURING A PROCEDURE, THE CLINICIAN NOTICED BLOOD IN THE WATER LINE. THE OXYGENATOR WAS CHANGED OUT AND THE CASE CONTINUED WITHOUT ANY FURTHER ISSUES. IT WAS STATED THAT THERE WAS BLOOD IN THE PT'S URINE WHEN COMING INTO THE OPERATING ROOM BUT THAT THIS CONDITION HAD IMPROVED BY THE END OF THE CASE. THERE WAS NO REPORT OF PT INJURY DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINE MED PORTLAND ME 1 CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 120450057

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR