BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILDRENS MED CINCINNATI OH 1

    MDR report key: 1468245 · Received July 23, 2009

    Report

    Report Number
    1718850-2009-00024
    Event Type
    Malfunction
    Date Received
    July 23, 2009
    Date of Event
    June 23, 2009
    Report Date
    June 23, 2009
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFUSIONIST REPORTED THAT DURING THE PROCEDURE, THE SMARXT TUBING ATTACHED TO THE VENOUS RESERVOIR OUTLET PORT SLIPPED OFF. THE PERFUSIONIST DID NOT RETURN THE PRODUCT TO SORIN GROUP USA FOR EVALUATION. THERE WAS NO INVENTORY OF THE REPORTED LOT AVAILABLE FOR FURTHER REVIEW. A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THE HEART LUNG PACK WAS MANUFACTURED TO SPECIFICATIONS. THE SMARXT TUBING SEPARATED FROM A CONNECTION MADE BY THE PERFUSIONIST. IT WAS REPORTED THAT THE PERFUSIONIST TIE BANDED THE CONNECTION PRIOR TO PRIMING THE CIRCUIT. THE SMARXT TUBING INSTRUCTIONS FOR USE, (B)(4), STATES THAT "IN ORDER TO PREVENT LEAKS OR TUBING DISCONNECTIONS, SORIN GROUP USA, INC. RECOMMENDS TIE BANDING SMARXT TUBING TO ALL BARBED CONNECTORS AND COMPONENT PORTS. PUSH THE PROPER SIZE TUBING AT LEAST 1/4 INCH PAST THE APEX OF THE INNERMOST BARB AND SECURELY TIE WRAP." SORIN GROUP USA, INC. RECOMMENDS FOLLOWING THESE STEPS IN ORDER TO PREVENT ANY TYPE OF TUBING TO CONNECTOR SEPARATION. THE CAUSE OF THE REPORTED SEPARATION CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT THE TUBING ATTACHED TO THE VENOUS RESERVOIR OUTLET PORT SLIPPED OFF. THE CONNECTION REMAINED STERILE ALLOWING THE PERFUSIONIST TO IMMEDIATELY RECONNECT THE TUBING AND DE-AIR THE CIRCUIT. BLOOD LOSS WAS APPROXIMATELY 150 - 200 CC. THERE WAS NO REPORT OF PATIENT INJURY AND THE PATIENT WAS DISCHARGED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDRENS MED CINCINNATI OH 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA, INC. NA 0719000095

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR