BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE

    MDR report key: 3955675 · Received July 21, 2014

    Report

    Report Number
    1718850-2014-00227
    Event Type
    Other
    Date Received
    July 21, 2014
    Date of Event
    June 7, 2014
    Report Date
    February 6, 2017
    Manufacturer
    SORIN GROUP DEUTCHSLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES TO THE STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE. 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 THE STOCKERT S3 ROLLER PUMP STOPPED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 CONSOLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE TESTED THE DEVICE BUT WAS NOT ABLE TO CONFIRM THE REPORTED FAILURE. THE DEVICE OPERATED WITHOUT MALFUNCTION. THE CUSTOMER HAS SINCE REPLACED THE S3 CONSOLE WITH A NEW SORIN S5 SYSTEM AND REPORTED THAT THEY PLANNED TO SCRAP THE S3. AS THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE STOCKERT S3 ROLLER PUMP STOPPED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426362 STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTCHSLAND 43-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP