BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBIGN CLAMP

    MDR report key: 3912346 · Received June 27, 2014

    Report

    Report Number
    1718850-2014-00198
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 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
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCP DISPLAYED AN ERROR MESSAGE, THE FLOW RATE COULD NOT BE ADJUSTED AND THE DISPLAY INDICATED A PUMP SPEED OF 0 EVEN THOUGH THE PUMP HEAD WAS ROTATING. AFTER CHANGING THE CROSS-CLAMP THE FLOW RETURNED TO NORMAL BUT THE PUMP SPEED STILL COULD NOT BE ADJUSTED WITH THE KNOB. THE USER ELECTED TO CONTROL THE FLOW RATE MANUALLY TO COMPLETE THE PROCEDURE. 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 (B)(4) RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCP DISPLAYED AN ERROR MESSAGE, THE FLOW RATE COULD NOT BE ADJUSTED AND THE DISPLAY INDICATED A PUMP SPEED OF 0 EVEN THOUGH THE PUMP HEAD WAS ROTATING. AFTER CHANGING THE CROSS-CLAMP THE FLOW RETURNED TO NORMAL BUT THE PUMP SPEED STILL COULD NOT BE ADJUSTED WITH THE KNOB. THE USER ELECTED TO CONTROL THE FLOW RATE MANUALLY TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376296 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBIGN CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND. 60-01-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR