BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 3894215 · Received June 16, 2014

    Report

    Report Number
    1718850-2014-00185
    Event Type
    Other
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE S5 DOUBLE HEAD 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 THE S5 DOUBLE HEAD PUMP DISPLAYED AN ERROR WHILE THE CLINICIAN WAS ATTEMPTING TO CIRCULATE THE CARDIOPLEGIA PRIOR TO GOING ONTO BYPASS. THERE WAS NO PT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE S5 DOUBLE HEAD PUMP DISPLAYED AN ERROR WHILE THE CLINICIAN WAS ATTEMPTING TO CIRCULATE THE CARDIOPLEGIA PRIOR TO GOING ONTO BYPASS. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353136 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-85-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP