BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 3952356 · Received July 18, 2014

    Report

    Report Number
    1718850-2014-00231
    Event Type
    Other
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5/C5 SENSOR MODULE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT S5/C5 SENSOR MODULE DID NOT FUNCTION DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT S5/C5 SENSOR MODULE DID NOT FUNCTION DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422544 SORIN CENTRIFUGAL PUMP 5 (CP5) CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA SORIN GROUP DEUTSCHLAND 25-60-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP