BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 3982650 · Received July 25, 2014

    Report

    Report Number
    1718850-2014-00253
    Event Type
    Other
    Date Received
    July 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SCP CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(6). SORIN GROUP RECEIVED A REPORT THAT BEFORE GOING ON BYPASS, THE SCP CENTRIFUGAL PUMP SYSTEM DISPLAYED A FLOW VALUE EVEN THOUGH THE TUBING WAS CLAMPED AND NO FLUID WAS FLOWING. THE ISSUE WAS RESOLVED PRIOR TO GOING ON BYPASS AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT OF THAT BEFORE GOING ON BYPASS, THE SCP CENTRIFUGAL PUMP SYSTEM DISPLAYED A FLOW VALUE EVEN THOUGH THE TUBING WAS CLAMPED AND NO FLUID WAS FLOWING. A ISSUE WAS RESOLVED PRIOR TO GOING ON BYPASS AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436692 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 60-00-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1