BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PACK 1J28R6 3/8 ECMO

    MDR report key: 1294803 · Received January 15, 2009

    Report

    Report Number
    2184009-2009-00001
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    November 5, 2008
    Report Date
    December 17, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWE
    PMA / PMN Number
    K800178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE CIRCUIT USED IN THE ECMO CASE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, VISUAL INSPECTION OF PHOTOS OF THE CIRCUIT CONFIRMED THE TUBING DISCONNECTION, AS BODY FLUID CONTAMINATION WAS FOUND ON THE CIRCUIT AND ECMO EQUIPMENT. THE EXACT LOCATION OF THE LEAK COULD NOT BE VERIFIED BY THE PHOTOS ALONE. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED. THE CUSTOMER NOTED THAT RECORDING LOT NUMERS OF PRODUCT USED IN ECMO CASES WILL BECOME STANDARD PRACTICE FOR FUTURE CASES. CONCLUSION: USER INTERFACE CONTRIBUTED TO THIS EVENT, AS THE ECMO SPECIALIST MANUALLY INCREASED THE PRESSURE IN THE CIRCUIT, WHICH CAUSED THE TUBING TO DISCONNECT, SPRAYING BODY FLUID CONTAMINATION IN THE FIELD. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY NOTES EXTENSIVE TRAINING WAS GIVEN TO ECMO STAFF TO MITIGATE THIS ISSUE FROM RECURRING. MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT ANOTHER MANUFACTURER'S OXYGENATOR WAS OCCLUDED BY A CLOT. THE ECMO SPECIALIST FAILED TO RECOGNIZE THE OCCLUSION. MEDTRONIC RECEIVED ADDITIONAL INFO THAT AFTER RECOGNIZING THE CLOT, IN A SPLIT SECOND DECISION, THE ECMO SPECIALIST MANUALLY HAND-CRANKED THE OTHER MANUFACTURER'S PUMP, THEREBY INCREASING THE CIRCUIT PRESSURE UNTIL THE CONNECTIONS COULD NO LONGER WITHSTAND THE STRESS. THE TUBING CONNECTION RUPTURED, SPRAYING BODY FLUID OUT OF THE CIRCUIT INTO THE MOUTH, NOSE, EYES AND EARS OF THE STAFF. THE PT HAS A HISTORY OF HEPATITIS C. DUE TO HEPATITIS C EXPOSURE, THE HOSPITAL STAFF REQUIRED MEDICAL INTERVENTION. THERE WERE NO ADVERSE PT OUTCOMES REPORTED. THE CIRCUIT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PACK 1J28R6 3/8 ECMO DWE DWE MEDTRONIC PERFUSION SYSTEMS 1J28R6 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention| S