BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5DOUBLE HEAD PUMP

    MDR report key: 4863427 · Received June 17, 2015

    Report

    Report Number
    9611109-2015-00190
    Event Type
    Other
    Date Received
    June 17, 2015
    Date of Event
    May 14, 2015
    Report Date
    March 27, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF (B)(4). A (B)(4) FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS NOT ABLE TO REPRODUCE OR CONFIRM THE REPORTED FAILURE. AS A PRECAUTION, ALL CONNECTIONS WERE RESEATED AND SUBSEQUENT TESTING OF THE DEVICE WAS CONDUCTED WITHOUT ISSUE. THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT POST PROCEDURE, THE CARDIOPLEGIA PUMP STOPPED. AS THIS OCCURRED AFTER THE CASE, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT POST PROCEDURE, THE CARDIOPLEGIA PUMP STOPPED. AS THIS OCCURRED AFTER THE CASE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392741 S5DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND GMBH 10-85-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA