BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 3163085 · Received May 31, 2013

    Report

    Report Number
    1718850-2013-00094
    Event Type
    Other
    Date Received
    May 31, 2013
    Report Date
    May 6, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN (B)(4) MANUFACTURES THE S3 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). SORIN (B)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP STOPPED AND DISPLAYED AN ERROR MESSAGE DURING PRIMING. THE PUMP WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN (B)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP STOPPED AND DISPLAYED AN ERROR MESSAGE DURING PRIMING. THE PUMP WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241255 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-60-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA