BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP.

    MDR report key: 4863447 · Received June 17, 2015

    Report

    Report Number
    9611109-2015-00223
    Event Type
    Other
    Date Received
    June 17, 2015
    Date of Event
    May 11, 2015
    Report Date
    March 27, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SERIAL NUMBER PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THE CORRECT DEVICE SERIAL NUMBER IS (B)(4). THE DEVICE MANUFACTURE DATE PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THE CORRECT DEVICE MANUFACTURE DATE IS JULY 6, 2007. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE IDENTIFIED A FAULTY DRIVE UNIT WHICH WAS REMOVED AND RETURNED TO LIVANOVA (B)(4) FOR INVESTIGATION. THE REPORTED ISSUE COULD NOT BE REPRODUCED AT LIVANOVA (B)(4). THE DEVICE WAS CLEANED AND DISINFECTED AND A TEST RUN OF 24 HOURS WAS PERFORMED WITHOUT ISSUE. AS THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING INSTALLATION THE CENTRIFUGAL PUMP HAD AN INTERMITTENT FAILURE. THE FLOW DISPLAY SHOWED DASHES, ALARMED AND THEN RETURNED TO NORMAL. THERE WAS NO PATIENT INVOLVEMENT. 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 INSTALLATION, THE CENTRIFUGAL PUMP HAD AN INTERMITTENT FAILURE. THE FLOW DISPLAY SHOWED DASHES, ALARMED AND THEN RETURNED TO NORMAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394288 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS. DWA SORIN GROUP DEUTSCHLAND GMBH 60-01-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA