BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 7116322 · Received December 14, 2017

    Report

    Report Number
    9611109-2017-01013
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Report Date
    April 17, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE REPLACED THE TOUCH SCREEN TO RESOLVE THE REPORTED ISSUE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE DATE OF EVENT HAS NOT BEEN PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT IF MADE AVAILABLE. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE TOUCHSCREEN OF THE CENTRIFUGAL PUMP 5 (CP5) BECAME UNRESPONSIVE DURING PRIMING. THE TOUCHSCREEN WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896882 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-02-60

    Patients

    Seq Age Sex Outcome Treatment
    1