BEUDAMED
    FDA Adverse Event Other Summary report: N

    C21617 DE LIFE SYSTEMS $PHISIO

    MDR report key: 3445218 · Received October 24, 2013

    Report

    Report Number
    1718850-2013-00261
    Event Type
    Other
    Date Received
    October 24, 2013
    Date of Event
    September 13, 2013
    Report Date
    October 21, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CUSTOMER PERFUSION PACK. THE COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC IS A COMPONENT OF THE PERFUSION PACK. THE 510(K) NUMBER OF THE PUMP HEAD IS K030462. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE DISPOSABLE PUMP HEAD WAS NOT SEATED PROPERLY INTO THE DRIVE UNIT OF THE STOCKERT CENTRIFUGE PUMP SYSTEM WHICH CAUSED THE PUMP HEAD TO OVERHEAT DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546174 C21617 DE LIFE SYSTEMS $PHISIO CUSTOMER PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1210290026

    Patients

    Seq Age Sex Outcome Treatment
    1