BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA ADAPTERS

    MDR report key: 6136998 · Received November 30, 2016

    Report

    Report Number
    1718850-2016-00399
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    September 12, 2016
    Report Date
    November 3, 2016
    Manufacturer
    SORIN GROUP USA, INC
    Product Code
    DWF
    PMA / PMN Number
    K993818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED. PATIENT WEIGHT WAS NOT PROVIDED. (B)(4). THE CUSTOMER HAS BEEN CONTACTED REGARDING THE DEVICE AVAILABILITY. HOWEVER, THE CONTACT DID NOT KNOW IF THE DEVICE IS AVAILABLE FOR RETURN TO SORIN GROUP USA AND FORWARDED THE REQUEST TO ANOTHER INDIVIDUAL AT THE FACILITY. IT IS STILL UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, SORIN GROUP RECEIVED A USER MEDWATCH REPORT ((B)(4)) STATING THAT THE RED TAPED EXTENSION THAT SCREWS ONTO CARDIOPLEGIA ADAPTER CAUSED A HIGH LINE PRESSURE FROM THE HEART LUNG MACHINE WHEN TRYING TO ADMINISTER CARDIOPLEGIA TO STOP THE HEART. THE CARDIOPLEGIA SYSTEM WAS CHANGED OUT TO A NEW DEVICE FROM THE SAME LOT AND CARDIOPLEGIA WAS ABLE TO FLOW AT AN APPROPRIATE PRESSURE. THIS ISSUE CAUSED A DELAY IN THE DELIVERY OF CARDIOPLEGIA AND THE HEART WAS NOT STOPPED IN THE EXPECTED TIME FRAME. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786724 CARDIOPLEGIA ADAPTERS CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC 1621500043

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR