BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 5112565 · Received September 30, 2015

    Report

    Report Number
    9611109-2015-00385
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WHEN THE S5 ROLLER PUMP IS SWITCHED ON, THE PANEL OF THE PUMP TURNS BLACK AND AN ALARM MESSAGE OF "GRAPHIQUE DISPLAY FAILURE PUMP 3" APPEARS. THE MALFUNCTION OCCURRED DURING SETUP AND THERE WAS NO PATIENT INVOLVED. 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 S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6) . THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WHEN THE S5 ROLLER PUMP IS SWITCHED ON, THE PANEL OF THE PUMP TURNS BLACK AND AN ALARM MESSAGE OF "GRAPHIQUE DISPLAY FAILURE PUMP 3" APPEARS. THE MALFUNCTION OCCURRED DURING SETUP AND THERE WAS NO PATIENT INVOLVED. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND TRACED THE FAULT BACK TO THE HKR BOARD. THE HKR BOARD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE REPLACED BOARD WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. DURING ANALYSIS, THE ROOT CAUSE WAS IDENTIFIED TO BE A DEFECTIVE SOLDERING JOINT. THE SOLDERING JOINT WAS REPAIRED AND SUBSEQUENT TESTING FOUND THE DEVICE TO BE WORKING CORRECTLY. THE RETURNED HKR BOARD WAS SCRAPPED UPON COMPLETION OF THE EVALUATION. 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 RECEIVED A REPORT THAT WHEN THE S5 ROLLER PUMP IS SWITCHED ON, THE PANEL OF THE PUMP TURNS BLACK AND AN ALARM MESSAGE OF "GRAPHIQUE DISPLAY FAILURE PUMP 3" APPEARS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645824 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-80-00 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR