BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOWA METH DES MOINES IA 1

    MDR report key: 2182104 · Received June 23, 2011

    Report

    Report Number
    1718850-2011-00063
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 26, 2011
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A REPORT THAT A CRACKED CONNECTOR IN THE CARDIOPLEGIA LINE CAUSED BLOOD TO LEAK AND AIR TO BE ASPIRATED. THIS RESULTED IN A DELAY OF ABOUT 10 MINUTES WHILE THE PT WAS ON PUMP, BUT BEFORE CROSS-CLAMP. THE CONNECTOR WAS REPLACED AND THE CASE CONTINUED WITHOUT FURTHER ISSUES. NO AIR REACHED THE PT AND THERE WERE NO PT COMPLICATIONS DUE TO THE INCIDENT. NO MEDICAL INTERVENTION WAS REQUIRED. THE CONNECTOR WHICH LEAKED WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. WHILE NO CRACK WAS FOUND IN THE CONNECTOR, LEAK TESTING CONFIRMED THE PRESENCE OF A LEAK. A CAPA HAS BEEN INITIATED AND THE ROOT CAUSE DETERMINED. THE CONNECTOR DIMENSIONS WERE OUT OF SPECIFICATION. CORRECTIVE ACTION HAS BEEN IMPLEMENTED BY THE SUPPLIER. THE MFG PROCESS HAS BEEN ADJUSTED TO BRING THE CONNECTOR DIMENSIONS BACK INTO SPECIFICATION. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT A CRACKED CONNECTOR IN THE CARDIOPLEGIA LINE CAUSED BLOOD TO LEAK AND AIR TO BE ASPIRATED. THIS RESULTED IN A DELAY OF ABOUT 10 MINUTES WHILE THE PT WAS ON PUMP, BUT BEFORE CROSS-CLAMP. THE CONNECTOR WAS REPLACED AND THE CASE CONTINUED WITHOUT FURTHER ISSUES. NO AIR REACHED THE PT AND THERE WERE NO PT COMPLICATIONS DUE TO THE INCIDENT. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOWA METH DES MOINES IA 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1033500001

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR