BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN CENTRIFUGAL PUMP SYSTEM SCP

    MDR report key: 5240680 · Received November 20, 2015

    Report

    Report Number
    9611109-2015-00527
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 7, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP DEUTSCHLAND MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM SCP. THE INCIDENT OCCURRED IN (B)(6) USA. THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP DEUTSCHLAND. SORIN GROUP DEUTSCHLAND GMBH RECEIVED A REPORT THAT THE SCP CONTROL PANEL DISPLAYED AN ERROR MESSAGE DURING A PROCEDURE. THE OPERATOR SWITCHED THE DEVICE WITH A SIMILAR ONE TO COMPLETE THE CASE. 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

    THE "DATE RECEIVED BY MANUFACTURER" IN FOLLOW-UP 1 FILED APRIL 19, 2016 WAS INCORRECTLY INDICATED AS MARCH 30, 2015. THE CORRECT ALERT DATE FOR THE NEW INFORMATION CONTAINED IN FOLLOW-UP 1 IS MARCH 30, 2016.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM SCP. 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 SCP CONTROL PANEL DISPLAYED AN ERROR MESSAGE DURING A PROCEDURE. THE OPERATOR SWITCHED THE DEVICE WITH A SIMILAR ONE TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE BUT WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE UNIT WAS RUN FOR 2 HOURS WITH NO ERRORS. A CPU BOARD WAS REPLACED AS A PRECAUTION. THE UNIT WAS TESTED AND FOUND TO BE WORKED PROPERLY. AS THE REPORTED ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED, THOUGH CONSULTATION WITH A SORIN GROUP (B)(4) TECHNICIAN REVEALED THAT THE REPORTED ISSUE CAN BE CAUSED DUE TO A FAULTY EPROM-CHIP ON THE CPU BOARD THAT WAS REPLACED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. NO TREND HAS BEEN IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS. EVALUATED ON SITE BY SORIN SERVICE REP.

    Description of Event or Problem · 1

    SORIN GROUP DEUTSCHLAND GMBH RECEIVED A REPORT THAT THE SCP CONTROL PANEL DISPLAYED AN ERROR MESSAGE DURING A PROCEDURE. THE OPERATOR SWITCHED THE DEVICE WITH A SIMILAR ONE TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769943 SORIN CENTRIFUGAL PUMP SYSTEM SCP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND GMBH 60-02-15 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1