BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCSG PENNSY HSP PHILDLPHIA PA1

    MDR report key: 1047816 · Received May 16, 2008

    Report

    Report Number
    1718850-2008-00011
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 18, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTN
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CSC14 IS MANUFACTURED BY INT'L AFFILIATE, AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 088118600, IS PRE-AMENDMENT DEVICE. ONE CSC14 CARDIOPLEGIA SET WAS RETURNED TO SORIN GROUP USA, INC. FOR EVAL. A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. THE RESIDUAL BLOOD SEEN IN THE DEVICE APPEARED CLOTTED. LEAK TESTING WAS PERFORMED ON THE DEVICE AT VARIOUS TEMPERATURES AND PRESSURES CHALLENGING BOTH THE BLOOD SIDE AND WATER SIDE OF THE HEAT EXCHANGER. NO LEAKS WERE IDENTIFIED. THE UNIT WAS RETURNED TO SORIN GROUP ITALIA FOR FURTHER EVAL. A FOLLOW-UP REPORT WILL BE FILED WITH INT'L AFFILIATE'S FINDINGS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PERFUSIONIST NOTICED THAT THE WATER CIRCULATING THROUGH THE CSC14 CARDIOPLEGIA UNIT HAD A PINK TINGE. THE SURGEON STATED THAT NO ADD'L CARDIOPLEGIA WAS REQUIRED FOR THE CASE AND THEREFORE, THE UNIT WAS NOT CHANGED OUT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCSG PENNSY HSP PHILDLPHIA PA1 CUSTOM PERFUSION PACK DTN SORIN GROUP USA, INC. NA 0803500152

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR