BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2912919 · Received December 19, 2012

    Report

    Report Number
    1718850-2012-01104
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 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
    WA, 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). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE THE TUBING BUNCHED IN THE RACEWAY OF THE S5 ROLLER PUMP AND THE PUMP MOTOR STALLED. AN ERROR MESSAGE WAS DISPLAYED. THE CLINICIAN READJUSTED THE TUBING AND RESTARTED THE PUMP. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PT INJURY. 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 REPORT THAT DURING A PROCEDURE THE TUBING BUNCHED IN THE RACEWAY OF THE S5 ROLLER PUMP AND THE PUMP MOTOR STALLED. AN ERROR MESSAGE WAS DISPLAYED. THE CLINICIAN READJUSTED THE TUBING AND RESTARTED THE PUMP. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO 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 NP