BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY CP CENTRIFUGAL PUMP

    MDR report key: 7581539 · Received June 8, 2018

    Report

    Report Number
    2184009-2018-00012
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    January 1, 2017
    Report Date
    July 18, 2018
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWE
    PMA / PMN Number
    K080824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AND NO DEFINITIVE CONCLUSIONS CAN BE MADE REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION; BRAND NAME; AFFINITY CP CENTRIFUGAL PUMP. PRODUCT CODE: DWE. MODEL: CBAP40, LOT#: UNKNOWN, UDI: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE BIO-CONSOLE INSTRUMENT AND CENTRIFUGAL PUMP, THE CUSTOMER HEARD A GRINDING NOISE, FORWARD FLOW DIMINISHED AND BLOOD PRESSURE DROPPED. THE BIO-CONSOLE INSTRUMENT HANDCRANK WAS USED FOR APPROXIMATELY 5 MINUTES. DURING HANDCRANKING A CLOT WAS NOTICED IN THE CENTRIFUGAL PUMP. THE CENTRIFUGAL PUMP WAS REPLACED. THE BIO-CONSOLE INSTRUMENT WAS REPLACED WITH A BACKUP. THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424292 AFFINITY CP CENTRIFUGAL PUMP TUBING, PUMP, CARDIOPULMONARY BYPASS DWE PERFUSION SYSTEMS CBAP40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention