BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2912827 · Received December 3, 2012

    Report

    Report Number
    1718850-2012-01074
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. 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 RECEIVED A REPORT THAT DURING THE PROCEDURE THE ARTERIAL PUMP STOPPED. THE PERFUSIONIST HAND-CRANKED TO MAINTAIN BLOOD FLOW FOR THE REMAINDER OF THE CASE. THERE WAS NO PT INJURY. A SORIN GROUP FIELD SERVICE REP WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. EVAL OF THE PUMP AT THE FACILITY FOUND NO PROBLEMS. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING THE PROCEDURE, THE ARTERIAL PUMP STOPPED. THE PERFUSIONIST HAND-CRANKED TO MAINTAIN BLOOD FLOW FOR THE REMAINDER OF THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1