BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 4863445 · Received June 16, 2015

    Report

    Report Number
    9611109-2015-00191
    Event Type
    Other
    Date Received
    June 16, 2015
    Date of Event
    May 18, 2015
    Report Date
    March 27, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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). THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF (B)(4). A (B)(4) FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE TESTED THE DEVICE AND WAS NOT ABLE TO REPRODUCE OR CONFIRM THE REPORTED FAILURE. DURING INVESTIGATION, THE SERVICE REPRESENTATIVE FOUND THAT THE CURRENT OFFSET WAS TOO HIGH. THE HUS BOARD AND UPS MODULE WERE REPLACED TO RESOLVE THE CURRENT OFFSET ISSUE AND SUBSEQUENT TESTING DID NOT IDENTIFY FURTHER FAILURES. THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING THE PROCEDURE, THE PUMP STOPPED. THE PUP WAS POWER CYCLED AND THE CASE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389966 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND GMBH 100-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1