BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUBBLE DETECTOR CABLE - ADULT

    MDR report key: 1883694 · Received October 18, 2010

    Report

    Report Number
    2184009-2010-00024
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K051303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: EVALUATION OF THE BIOCONSOLE FOUND THAT THIS UNIT PERFORMED AS INTENDED WITH NO ISSUES. THE BUBBLE DETECTOR WAS RETURNED TO MEDTRONIC FOR ANALYSIS. VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF DAMAGE. FUNCTIONAL TESTING FOUND THAT THE BUBBLE DETECTOR WAS NOT OVERLY SENSITIVE. THE DEVICE OPERATED WITH SPECIFICATION. IN AN EFFORT TO REPRODUCE AN INACCURATE BUBBLE ALARM, THE TUBING WAS MOVED WITHIN THE SENSOR; HOWEVER, THIS REQUIRED A SIGNIFICANT AMOUNT OF MOVEMENT TO TRIGGER. DEVICE HISTORY REVIEW IS PENDING. A SUPPLEMENTAL REPORT WILL BE FILED ONCE COMPLETE. CONCLUSION: BASED ON THE AVAILABLE INFORMATION, IT WAS CONCLUDED THAT THIS EVENT WAS CAUSED BY OPERATIONAL CONTEXT. IT IS POSSIBLE THAT THE BUBBLE ALARM TRIGGERED AN ALARM IF THE TUBING WAS MOVED WITHIN THE SENSOR. DURING TESTING, THE TUBING HAD TO BE MOVED SIGNIFICANTLY TO REPRODUCE THIS INACCURATE BUBBLE ALARM TO BE TRIGGERED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING BYPASS, THE BUBBLE DETECTOR ALARM WENT OFF. THE BIOCONSOLE STOPPED FLOW IN RESPONSE TO THE BUBBLE DETECTOR ALARM, AS PROGRAMMED. THE BUBBLE SENSOR WAS REPOSITIONED, AND THE BIOCONSOLE RESTARTED. THE BUBBLE DETECTOR AGAIN WENT OFF. THE SENSOR AND SENSOR LINES WERE EXAMINED AND PROPER POSITIONING WAS VERIFIED. THE BIOCONSOLE WAS AGAIN RESTARTED. THIS OCCURRED 4 TIMES TOTAL. IT WAS REPORTED THAT DURING THE TROUBLESHOOTING FOR THE BUBBLE SENSOR, THE PATIENT'S BLOOD PRESSURES REACHED AN UNSAFE LEVEL. FOR THE REST OF THE CASE, THE BUBBLE DETECTOR DID NOT GO OFF AGAIN. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PATIENT RECOVERED IN A NORMAL FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE DETECTOR CABLE - ADULT ACCESSORY DWA MEDTRONIC PERFUSION SYSTEMS BD38 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening