BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSEPT

    MDR report key: 6023713 · Received October 12, 2016

    Report

    Report Number
    2184009-2016-00018
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 20, 2016
    Report Date
    November 2, 2016
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWE
    PMA / PMN Number
    K800178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITH THE AVAILABLE INFORMATION, MEDTRONIC IS UNAWARE OF HOW LONG THE PRODUCT WAS IN USE BEFORE THE DISCONNECTION OCCURRED. MEDTRONIC'S INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO MEDTRONIC FOR ANALYSIS. IN AN EFFORT TO IDENTIFY THE POTENTIAL ROOT CAUSE, SAMPLE LINES WERE CONSTRUCTED AND TESTED. AT THIS TIME MEDTRONIC CANNOT CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE, AS THE COMPLAINT PRODUCT WAS NOT RETURNED AND THE ISSUE COULD NOT BE DUPLICATED THROUGH STRESS TESTING OF SAMPLE LINES. MEDTRONIC¿S MANUFACTURING FACILITY HAS ADDED A SILICONE BAND TO THE CONNECTION FOR FUTURE PRODUCT ASSEMBLIES. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE EVENTS AND OCCURRENCES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, A DISCONNECTION OCCURRED BETWEEN TUBING FROM THIS MEDTRONIC PERFUSION PACK AND A FEMORAL ARTERIAL CANNULA. THE PATIENT SUFFERED BLOOD LOSS, BUT THE TOTAL AMOUNT LOST WAS UNKNOWN. THE PATIENT RECEIVED 3 TO 4 UNITS OF TRANSFUSED BLOOD TO ADDRESS THE LOSS. THE PERFUSION LINE WAS REPLACED. THE MOST RECENT INFORMATION MEDTRONIC HAS RECEIVED INDICATED THE PATIENT WAS STILL ON ECMO SUPPORT. MEDTRONIC HAS REQUESTED RETURN OF THE PRODUCT, BUT IT HAS NOT BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671456 INTERSEPT TUBING, PUMP, CARDIOPULMONARY BYPASS DWE PERFUSION SYSTEMS 0W17R3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention