BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCY HSP PITTSBURGH PA 1

    MDR report key: 1439050 · Received May 7, 2009

    Report

    Report Number
    1718850-2009-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    April 7, 2009
    Report Date
    April 7, 2009
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER FOR THE SYNTHESIS OXYGENATOR IS K073380. THE SYNTHESIS IS MANUFACTURED BY SORIN GROUP AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 087400600, IS A PRE-AMENDMENT DEVICE. ONE SYNTHESIS OXYGENATOR WAS RETURNED TO SORIN GROUP USA, INC. FOR EVALUATION. A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. LEAK TESTING OF THE DEVICE DID IDENTIFY A LEAK PATH BETWEEN THE BLOOD SIDE AND WATER SIDE OF THE HEAT EXCHANGER. THE OXYGENATOR WAS RETURNED TO SORIN GROUP FOR FURTHER EVALUATION. A FOLLOW-UP WILL BE FILED WITH SORIN GROUP FINDINGS.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED A PINK TINGE IN THE HEAT EXCHANGER WATER LINES ATTACHED TO THE OXYGENATOR. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCY HSP PITTSBURGH PA 1 CUSTOM PERFUSION PACK DWE SORIN GROUP ITALIA NA 0833600157

    Patients

    Seq Age Sex Outcome Treatment
    1