BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2935403 · Received January 24, 2013

    Report

    Report Number
    1718850-2012-01124
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 31, 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
    VM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. 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 (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 ROLLER PUMP WAS UNRESPONSIVE DURING PRIMING. THE REPORT INDICATED THAT THE PUMP DID NOT STOP AS A RESULT OF THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE OCCURRED DURING PRIMING. SORIN GROUP (B)(4) HAS REQUESTED THAT THE PUMP BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 ROLLER PUMP WAS UNRESPONSIVE DURING PRIMING. THE REPORT INDICATED THAT THE PUMP DID NOT STOP AS A RESULT OF THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE OCCURRED DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34765 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1