BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALAMO PERF SAN ANTONIO TX1

    MDR report key: 1139783 · Received August 28, 2008

    Report

    Report Number
    1718850-2008-00022
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 30, 2008
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN APEX OXYGENATOR, WITH A PIECE OF SMARXT TUBING ATTACHED TO THE MEMBRANE OUTLET PORT, WAS RETURNED TO SORIN GROUP USA, INC. FOR EVALUATION. A VISUAL INSPECTION SHOWED THE TUBING TO BE PUSHED PASSED THE FIRST TWO BARBS ON THE OXYGENATOR OUTLET PORT, BUT NOT PUSHED COMPLETELY UP TO THE PORT RIM. THE TUBING WAS NOT TIE WRAPPED. THE OXYGENATOR AND THE SMARXT TUBING WERE PRESSURE TESTED UNDER SIMULATED CLINICAL CONDITIONS FOR A PERIOD OF FOUR HOURS. THE TUBING DID NOT LEAK OR DISCONNECT. DIMENSIONAL ANALYSIS ON THE SMARXT TUBING CONFIRMED THAT THE INTERNAL DIAMETER AND WALL THICKNESS WERE WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THE HEART/LUNG PACK WAS MANUFACTURED TO SPECIFICATIONS. THE CAUSE OF THE REPORTED SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. THE SMARXT TUBING SEPARATED FROM A CONNECTION MADE BY THE PERFUSIONIST. ALTHOUGH IT WAS REPORTED THAT THE PERFUSIONIST ORIGINALLY TIE BANDED THE CONNECTION, THERE WAS NO VISUAL EVIDENCE ON THE RETURNED TUBING THAT INDICATED A TIE BAND HAD BEEN APPLIED. THE SMARXT TUBING INSTRUCTIONS FOR USE 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. NO FURTHER ACTION WAS DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING SET-UP, THE PERFUSIONIST CONNECTED TUBING TO THE ARTERIAL OUTLET OF THE OXYGENATOR. SHORTLY AFTER BYPASS WAS INITIATED, THE TUBING DISCONNECTED FROM THE OUTLET PORT. THE PERFUSIONIST RECONNECTED THE LINE AND COMPLETED THE CASE. BLOOD WAS GIVEN TO COMPENSATE FOR THE BLOOD LOSS. THERE WAS NO INJURY TO THE PATIENT DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALAMO PERF SAN ANTONIO TX1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 0724700059

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR