BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCSG HUP PHILADELPHIA PA 1

    MDR report key: 1073695 · Received July 1, 2008

    Report

    Report Number
    1718850-2008-00015
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 2, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VVR 4000I RESERVOIR WAS RETURNED TO THE SORIN GROUP USA, INC ON 06/24/08. A REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE VVR 4000I WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A VISUAL INSPECTION WAS PERFORMED ON THE RESERVOIR AND REVEALED THAT THE RESERVOIR DEFOAMER AND CARDIOTOMY FILTER MEDIA HAD BEEN COMPLETELY WETTED OUT WITH BLOOD. SEVERAL BLOOD CLOTS WERE ALSO OBSERVED IN THE CARDIOTOMY FILTER COMPARTMENT. THE CARDIOTOMY FILTER SECTION OF THE RESERVOIR WAS THEN TESTED WITH FLUID. THE MEASURED BREAKTHROUGH VOLUME WAS HIGHER THAN EXPECTED DUE TO EXCESSIVE CELLULAR DEPOSITION DURING USE. THE RESERVOIR WAS NEXT RINSED AND DRIED TO REMOVE THE DEPOSITION AND THEN RETESTED WITH FLUID. THE BREAKTHROUGH VOLUME WAS WITHIN SPECIFICATION. BASED ON THE DESCRIPTION OF THE EVENT AND THE LABORATORY ANALYSIS, THE RESERVOIR APPARENTLY BECAME BLOCKED AND PRESSURIZED AS A RESULT OF EXCESS SUCTION OF ACTIVATED BLOOD WITH DEBRIS DURING THE PROCEDURE. THIS IN TURN CAUSED THE TUBING ON THE PORT TO DISCONNECT, CONTAMINATING THE OPERATING PERSONNEL WITH BLOOD. THERE WERE NO DEFECTS FOUND WITH THE RETURNED RESERVOIR.

    Description of Event or Problem · 1

    TWO VENT LINES AND TWO CARDIOTOMY SUCTION LINES WERE ACTIVE THROUGHOUT A 2.5 HOUR CASE. JUST PRIOR TO COMING OFF BYPASS, THE VVR 4000I VENOUS RESERVOIR BECAME PRESSURIZED. AS A RESULT OF THE PRESSURE, THE QUICK PRIME LINE DISCONNECTED, AND SPRAYED THE OPERATING PERSONNEL WITH BLOOD. THE LINE WAS REATTACHED IMMEDIATELY. NO PERFORMANCE ISSUES OR NOTICEABLE CHANGES WERE NOTED PRIOR TO OR AFTER THE PRESSURIZATION. THERE WAS NO INTERVENTION AND NO ADVERSE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCSG HUP PHILADELPHIA PA 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 0809100121

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR