BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 4356792 · Received December 16, 2014

    Report

    Report Number
    1718850-2014-00476
    Event Type
    Other
    Date Received
    December 16, 2014
    Date of Event
    November 9, 2014
    Report Date
    November 19, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP. THE INCIDENT OCCURED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT, AFTER RUNNING FOR APPROXIMATELY 9 HOURS DURING A TRAINING SESSION, THE CP5 DISPLAYED AN ERROR MESSAGE AND RE-BOOTED ITSELF. THE INVESTIGATION FOUND NO PROBLEMS AFTER A 24 HOUR TEST RUN WITH DIFFERENT INTERVENTIONS. THE CP5 SUCCESSFULLY COMPLETED ALL TESTS. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE HKR BOARD WAS REPLACED AS A PRECAUTION. MANUFACTURING RECORDS SHOWED NO NONCONFORMITIES. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER RUNNING FOR APPROX 9 HRS DURING A TRAINING SESSION, THE CP5 DISPLAYED AN ERROR MESSAGE AND RE-BOOTED ITSELF. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825460 SORIN CENTRIFUGAL PUMP 5 (CP5) CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA SORIN GROUP DEUTSCHLAND 60-02-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA