BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 CONTROL PANEL MRP 85

    MDR report key: 3409237 · Received October 3, 2013

    Report

    Report Number
    1718850-2013-00203
    Event Type
    Other
    Date Received
    October 3, 2013
    Date of Event
    August 16, 2013
    Report Date
    September 5, 2013
    Manufacturer
    CORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONTROL PANEL MRP 85. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(6). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT WHEN THE FACILITY WAS PERFORMING MAINTENANCE ON THEIR S5 MAST ROLLER PUMPS, THE S5 MAST ROLLER PUMP CONTROL PANEL DISPLAYED SEVERAL ERROR MESSAGES AND THE PUMP STOPPED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501319 S5 CONTROL PANEL MRP 85 CONSOLER, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ CORIN GROUP DEUTSCHLAND 28-95-85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA