BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 11899606 · Received May 28, 2021

    Report

    Report Number
    9611109-2021-00300
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 27, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO SERVICE ACTIVITY HAS BEEN SCHEDULED YET FOR THIS UNIT. THROUGH FOLLOW UP COMMUNICATION IT WAS LEARNT THAT NO ERROR MESSAGE WAS DISPLAYED AND THAT THE CUSTOMER OWNS AN ADAPTER PLATE IN ORDER TO USE THE CP5 DRIVE UNIT IN COMBINATION WITH DISPOSABLE CENTRIFUGAL PUMP NOT MANUFACTURED BY LIVANOVA WHICH IS NOT IN ACCORDANCE WITH THE INSTRUCTION FOR USE. HOWEVER, THE USE OF THE ADAPTER PLACE FOR THIS SPECIFIC CASE WAS NOT CONFIRMED. THE ANALYSIS OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR ISSUES HAVE BEEN REPORTED FOR THIS CP5 DRIVE UNIT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE CENTRIFUGAL PUMP 5 (CP5) PUMP HEAD WAS WORKING INTERMITTENTLY DURING SERVICE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796527 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-01-04

    Patients

    Seq Age Sex Outcome Treatment
    1