BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITY DELTA

    MDR report key: 1113604 · Received August 14, 2008

    Report

    Report Number
    1220063-2008-00026
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 5, 2008
    Report Date
    August 7, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ALL INFO RECEIVED, DRAEGAR MEDICAL HAS NOT FOUND ANY EVIDENCE TO CONCLUDE THAT THE MONITOR WAS NOT PERFORMING AS INTENDED. OUR EVALUATION HAS CONFIRMED THAT THE ADVERSE EVENT REPORTED IS NOT A RESULT OF A DRAEGER MEDICAL DEVICE FAILURE. THE HOSPITAL BIOMEDS CHECKED THE MONITOR RIGHT AFTER THE PT EXPIRED WITH A BP SIMULATOR AND IT WAS ACCURATE. IN ADDITION, DRAEGER MEDICAL CHECKED THE MONITOR ON JULY 8, 2008 USING THE BP STIMULATOR AND DID SEVERAL VERY LOW BP'S AND SEVERAL VERY HIGH BP'S AND ALL READINGS WERE FOUND ACCURATE.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. RECEIVED INFO FROM OUR OFFICE IN (B) (4) THAT INCLUDES THE FOLLOWING CUSTOMER REPORT: INFO WITHIN THE NURSES NOTES STATED THAT "HEMODIALYSIS WAS STARTED ON THE PT INVOLVED, AROUND 1700 HOURS. AT APPROX THAT TIME, THE POSITION ART LINE STOPPED GIVING A READING. THE PT WAS ON 3 DIFFERENT INOTROPE DRUGS AT THE TIME. ONCE THE ART LINE GAVE WAY, HOSPITAL STAFF RELIED ON NIBP READINGS TO TITRATE DRUGS. WITH BP READINGS IN THE 200'S, THE STAFF DECREASED THE INOTROPE DRIPS OVER THE NEXT FEW HOURS, RESTARTING THE DRIPS WHENEVER BP READINGS DROPPED. AT 2115, AN INACCURATE NIBP OF 251/57 WAS NOTED WHEN STAFF MANUALLY MEASURED SBP OF LESS THAN 90 (ALL 3 DRIPS WERE REPORTED MAXED OUT AT THIS POINT). AT 2125 THE NIBP READ 200/72 AND THE STAFF BEGAN REDUCING THE INOTROPES (DESPITE HAVING NOTED THAT THE NIBP WAS INACCURATE 10 MINUTES BEFORE WITH A SBP OF 251). THEREAFTER, THE INOTROPES WERE CONTINUALLY REDUCED FOR A NIBP OF 192/30. AT 2220, IT WAS NOTED THAT BP WAS IMMEASURABLE VIA NIBP. AT 2222, NIBP READ 221/34 BUT A MANUAL CHECK OF BP SHOWED A SYSTOLIC OF <50. AT 2231 IT WAS AGAIN NOTED THAT THE NIBP READINGS WERE INACCURATE, MANUAL SBP WAS NOTED AT <90. THE PT EXPIRED AROUND 0400. THE HOSP BIOMEDS CHECKED THE MONITOR RIGHT AFTER THE PT EXPIRED WITH A BP STIMULATOR AND IT WAS ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DELTA PATIENT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. 5398435450

    Patients

    Seq Age Sex Outcome Treatment
    1 Death