BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN S3 ROLLER PUMP

    MDR report key: 1201445 · Received June 27, 2008

    Report

    Report Number
    1718850-2008-00013
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE SORIN S3 ROLLER PUMP IS MFG BY SORIN GROUP AND DISTRIBUTED BY SORIN GROUP USA, INC. THE MEDWATCH REPORT STATED THAT THE PUMP WAS REPLACED AND THAT THE VENDOR WOULD REPAIR THE PUMP. SORIN GROUP USA INC. SEARCHED THE RECORDS AND FOUND NO EVIDENCE THAT THE PUMP WAS PLACED BACK INTO SVC BY AN SGUSA REP. THE FACILITY HAS NOT RETURNED THE PUMP FOR EVAL. HOWEVER, THE REPORT DOCUMENTED THAT TESTING HAD BEEN DONE ON THE PUMP. TESTING COULD NOT DUPLICATE THE ERROR CODE. IT APPEARS THAT THE RELEVANT TESTS WERE PERFORMED BY THE FACILITY. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE RISK MGMT REP FOR ADDITIONAL INFO REGARDING THE STATUS OF THE PUMP. THE REP HAS NOT CONTACTED SGUSA. IF THE PRODUCT IS RETURNED OR ADDITIONAL INFO IS PROVIDED FROM THE FACILITY. A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1