BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT PURGE CONTROL (APC) SYSTEM

    MDR report key: 1705634 · Received May 26, 2010

    Report

    Report Number
    1718850-2010-00102
    Event Type
    Other
    Date Received
    May 26, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 26, 2010
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTZ
    PMA / PMN Number
    K041558
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APC CONTROL MODULE. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE CLINICIAN STATED THAT AIR WAS SEEN COMING FROM THE VENOUS LINE. AIR WAS DETECTED BY THE APC BUBBLE SENSOR AND THE PUMP STOPPED. THE OXYGENATOR WAS EMPTIED, RESULTING IN AIR BEING DELIVERED TO THE PATIENT. THERE WAS NO ELECTRICAL CLAMP OR BUBBLE SENSOR ON THE ARTERIAL LINE. SORIN GROUP (B)(4) RESPONDED THAT THE USER DID NOT USE THE CLAMP AND BUBBLE SENSOR AS RECOMMENDED BY THE INSTRUCTIONS FOR USE. THEY STATED THAT THIS INCIDENT WAS USER ERROR AND NOT A MALFUNCTION OF THE APC CONTROL MODULE. NO FURTHER ACTION IS DEEMED NECESSARY. THE SYNERGY INSTRUCTIONS FOR USE STATE THAT "THE USE OF A STOCKERT ELECTRIC REMOTE CLAMP (ERC) AND A BUBBLE SENSOR WITH SYNERGY IS HIGHLY RECOMMENDED".

    Description of Event or Problem · 1

    THE CLINICIAN STATED THAT AIR WAS SEEN COMING FROM THE VENOUS LINE. AIR WAS DETECTED BY THE APC BUBBLE SENSOR AND THE PUMP STOPPED. THE OXYGENATOR WAS EMPTIED, RESULTING IN AIR TO THE PATIENT. THERE WAS NO ELECTRICAL CLAMP OR BUBBLE SENSOR ON THE ARTERIAL LINE. THE PATIENT WAS MOVED TO A COMPRESSION CHAMBER. TO DATE, THE PATIENT STATUS IS STABLE. THE CLINICIAN STATED THAT IT WAS TOO DIFFICULT TO MANAGE THE APC MODULE IN AN EMERGENCY SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT PURGE CONTROL (APC) SYSTEM MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS DTZ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1