BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 5884652 · Received August 17, 2016

    Report

    Report Number
    9611109-2016-00515
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    July 21, 2016
    Report Date
    March 21, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN CENTRIFUGAL PUMP 5 (CP5) BRIEFLY POWERED OFF BY ITSELF ON 3 OCCASIONS IN A 20 MINUTE PERIOD DURING A PROCEDURE. EACH TIME, THE CP5 CAME BACK ON BY ITSELF AFTER A FEW SECONDS. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE TURNED ON THE UNIT AND WAS ABLE TO REPRODUCE THE ISSUE. NO ERROR CODES WERE DISPLAYED. THE UNIT WAS TESTED WITH A DIFFERENT S5 HEART-LUNG MACHINE AND THE FAULT RECURRED. THE CP5 UNIT WAS REMOVED FROM SERVICE AND SENT TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF LIVANOVA (B)(4). THE DEVICE WAS RETURNED TO LIVANOVA (B)(4) FOR INVESTIGATION. A REVIEW OF THE PUMP READOUT DID NOT IDENTIFY ANY ISSUES ON THE REPORTED EVENT DATE. A LONG TEST RUN OF ABOUT 12 HOURS WAS PERFORMED WITH DIFFERENT ROTATION SPEEDS AND VARIOUS SIMULATED ALARMS. NO ISSUES WERE NOTED DURING THIS TIME. THE REPORTED ISSUES COULD NOT BE REPRODUCED. HOWEVER, VISUAL INSPECTION IDENTIFIED DAMAGE ON THE FRONT PANEL, WHICH LEAD TO A POOR CONNECTION BETWEEN THE HKR AND HKD BOARDS. LIVANOVA (B)(4) DETERMINED THIS TO BE THE ROOT CAUSE OF THE ISSUE. THE DAMAGED PARTS WERE REPLACED AND A TECHNICAL SAFETY INSPECTION WAS PERFORMED WITHOUT ISSUE. THE DEVICE WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN CENTRIFUGAL PUMP 5 (CP5) BRIEFLY POWERED OFF BY ITSELF ON 3 OCCASIONS IN A 20 MINUTE PERIOD DURING A PROCEDURE. EACH TIME, THE CP5 CAME BACK ON BY ITSELF AFTER A FEW SECONDS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534767 SORIN CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 60-02-60

    Patients

    Seq Age Sex Outcome Treatment
    1