BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 MAST ROLLER PUMP

    MDR report key: 2912945 · Received December 21, 2012

    Report

    Report Number
    1718850-2012-01110
    Event Type
    Other
    Date Received
    December 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K062396
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SORIN GROUP (B)(4) MANUFACTURES THE S5 MAST ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED OUT ON BEHALF OF SORIN GROUP (B)(4). IT WAS REPORTED THAT DILUTIONAL ULTRAFILTRATION AND TRANSFUSION WERE PERFORMED. AN UPDATE FROM THE PERFUSIONIST STATED THE PT WAS DOING WELL. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REQUEST FROM A CUSTOMER TO HAVE THE OCCLUSION OF THE S5 MAST ROLLER PUMP CHECKED OUT DUE TO A HEMOLYSIS ISSUE DURING A CASE. THE CLINICIAN STATED THE OCCLUSION WAS CHECKED PRE AND POST OPERATION AND WAS DEEMED TO BE APPROPRIATE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-88-0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1.1 MO Required Intervention