BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN S3 ROLLER PUMP

    MDR report key: 1097851 · Received April 30, 2008

    Report

    Report Number
    1718850-2008-00008
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWB
    PMA / PMN Number
    k950990
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MGMT REP WAS CONTACTED BY SORIN GROUP, USA INC. AFTER THE INCIDENT, THE PUMP WAS EVALUATED BY THE FACILITY'S BIOMEDICAL ENGINEER. THE SYS TESTED PROPERLY AND WAS RETURNED TO SVC. THE CONCLUSION WAS THAT THE FAILURE OCCURRED DUE TO AN OVER OCCLUSIVE PUMP AFTER TUBING HAD BEEN WALKED IN THE RACEWAY. THEREFORE, SORIN GROUP USA, INC. WAS NOT NOTIFIED OF THE EVENT AND THE PUMP WAS NOT RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN S3 ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS ROLLER TYPE DWB SORIN GROUP USA, INC. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1