BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM PACK TL6N06R1 ADULT

    MDR report key: 1944017 · Received December 23, 2010

    Report

    Report Number
    2184009-2010-00036
    Event Type
    Death
    Date Received
    December 23, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWE
    PMA / PMN Number
    K800178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED ON THE CANNULA, AS THE LOT NUMBER WAS NOT REPORTED. DEVICE HISTORY REVIEW OF THE TUBING CIRCUIT DID NOT SHOW ANY EVIDENCE OF ABNORMALITIES OR NONCONFORMANCE. CONCLUSION: BASED ON THE LIMITED AVAILABLE INFO, THE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED AT THIS TIME. IN FURTHER INVESTIGATION OF THIS EVENT, LEAK TESTING WAS PERFORMED AT 21 PSI (AIR) ON TUBING CIRCUIT SAMPLES TAKEN FROM MFG FLOOR, AND NO DETACHMENTS WERE PRESENTED. CIRCUITS WERE TESTED ON A ROLLER PUMP AND THE DEFECT WAS ONLY DUPLICATED WHEN PRESSURE REACHED (CLAMPING THE TUBING) 700 MMHG (13.5 PSI WITH SALINE SOLUTION). AVAILABLE TUBING LOTS WERE MEASURED TO STUDY THE POSSIBLE IMPACT OF THE DIMENSION VARIATION ON DISCONNECTION AND LEAK ISSUES, AND ALL WERE FOUND WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT JUST AS BYPASS WAS INITIATED, THE ARTERIAL FILTER BYPASS SECTION OF THE TUBING CIRCUIT DISCONNECTED. PRESSURES WERE BEING MONITORED AT THE TIME AND WERE REPORTED TO BE AT 260/270 AT 2 L/M FLOW. THE 3" SECTION OF TUBING BETWEEN THE INLET OF THE FILTER AND THE Y CONNECTOR DISCONNECTED AT THE ARM OF THE Y. IT WAS REPORTED THERE WAS NO TIE-BAND AT THE CONNECTION SITE. THE PT WAS TAKEN OFF BYPASS AND THE ENTIRE CIRCUIT WAS CHANGED OUT. DURING THE SAME PROCEDURE, THE CUSTOMER REPORTED THAT THERE WAS NO FLOW THROUGH THE CANNULA. PRIOR TO THE TUBING DISCONNECTION, THE CANNULA HAD BEEN INSERTED BUT NOT CONNECTED. AFTER REMOVING THE CLAMP, THERE WAS NO FLOW AND MANIPULATING THE CANNULA WAS NOT SUCCESSFUL. IT WAS CHANGED OUT AND IT APPEARED TO THE USER THAT THE HOLES WERE NOT PUNCHED OUT. IT WAS REPORTED THAT THE PT HAD BEEN SERIOUSLY ILL FOR SOME TIME AND THE PROCEDURE THAT WAS INITIALLY SCHEDULED FOR THE FUTURE WAS BEING PERFORMED AS AN EMERGENCY. ONCE THE CIRCUIT WAS CHANGED OUT, IT WAS DECIDED NOT TO PROCEED WITH THE PROCEDURE, AND THE PT EXPIRED. IT WAS REPORTED THAT THE SURGEON WAS NOT ATTRIBUTING THE DEATH OF THE PT TO THE EVENTS THAT OCCURRED OR THE PRODUCTS INVOLVED. THERE WILL BE NO PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PACK TL6N06R1 ADULT DWE MEDTRONIC PERFUSION SYSTEMS TL6N06R1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death