BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 3800526 · Received April 28, 2014

    Report

    Report Number
    1718850-2014-00125
    Event Type
    Other
    Date Received
    April 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP REC'D A REPORT THAT THE S5 ROLLER PUMP DISPLAYED AN ERROR DURING SET UP. THERE WAS NO PT INVOLVEMENT. A SORIN GROUP FIELD SERVICE REP WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. WHILE AT THE FACILITY, THE SERVICE REP COULD NOT CONFIRM THE ISSUE. THE SERVICE REP REPLACED THE MOTOR CONTROL BOARD AND THE POWER AMPLIFIER BOARD ON ROLLER PUMP 4. THE SERVICE REP FLASHED THE CP5. SUBSEQUENT TESTING FOUND THE EQUIPMENT TO BE FUNCTIONING PROPERLY. THE ORIGINAL BOARDS WERE RETURNED TO SGU FOR FURTHER EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP REC'D A REPORT THAT THE S5 ROLLER PUMP DISPLAYED AN ERROR DURING SET UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253428 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA