BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 5995574 · Received October 3, 2016

    Report

    Report Number
    9611109-2016-00636
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 7, 2016
    Report Date
    January 11, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF LIVANOVA (B)(4). THE AS RETURNED TO (B)(4) CONDITION OF P/N¿S 90-305-620 PCB, HKR0325 PROCESSOR, S5 L/N 07G102-B, 96-231-043 CABLE, RIBBON, TFT-DISPLAY, S5, 96-231-045 RIBBON CABLE 6POL.LCD/LED,S5, 97-101-954 WIRING LOADSPEAKER 280MM, S5, AND 97-103-617 LED DISPLAY W/TOUCHSCREEN S5 L/N 1A03D WAS; ALTHOUGH THE PACKAGING DID NOT PROVIDE ADEQUATE PROTECTION FOR EACH COMPONENT DURING SHIPPING, NO EVIDENCE OF PHYSICAL DAMAGE, MINOR EVIDENCE OF SPILLS ON THE TOUCH SCREEN. THE RESULT OF THE INVESTIGATION DOES NOT PROVIDE ANY EVIDENCE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. LIVANOVA HAS DETERMINED THAT A CAPA IS NOT REQUIRED, AS THERE WAS NO PATIENT HARM REPORTED. LIVANOVA WILL CONTINUE TO MONITOR THIS ISSUE FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. 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 TOUCH SCREEN OF THE S5 ROLLER PUMP WAS FOUND TO BE MALFUNCTIONING DURING SERVICE. THIS ISSUE WAS DISCOVERED BY A SORIN GROUP FIELD SERVICE REPRESENTATIVE DURING A SERVICE CALL. THERE WAS NO PATIENT INVOLVEMENT. THE SORIN GROUP FIELD SERVICE REPRESENTATIVE REPLACED THE LCD TOUCH SCREEN WITH A NEW LED TOUCH SCREEN. SUBSEQUENT TESTING DID NOT IDENTIFY FURTHER ISSUES. A TECHNICAL SAFETY INSPECTION WAS SUCCESSFULLY COMPLETED AND THE PUMP WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. 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 THE TOUCH SCREEN OF THE S5 ROLLER PUMP WAS FOUND TO BE MALFUNCTIONING DURING SERVICE. THIS ISSUE WAS DISCOVERED BY A SORIN GROUP FIELD SERVICE REPRESENTATIVE DURING A SERVICE CALL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646197 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1