BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500

    MDR report key: 3802274 · Received May 9, 2014

    Report

    Report Number
    1217157-2014-00065
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K113216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THIS EVENT IS UNKNOWN AND IS UNDER INVESTIGATION. THE CUSTOMER HAS BEEN INSTRUCTED TO DISCONTINUE USING THE RAPID POINT 500 INSTRUMENT PENDING OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURER'S INVESTIGATION INTO THIS EVENT AND DATA SIEMENS WAS ABLE TO OBTAIN FROM THE CUSTOMER, THE INDICATION IS THAT BOTH INSTRUMENTS WERE PERFORMING AS EXPECTED. BASED ON THE SIEMENS MEDICAL AFFAIRS ASSESSMENT, THE USE OF INTRALIPID AS A LIPOPHILIC DRUG SINK IN THIS SITUATION MAY HAVE HAD AN EFFECT ON THE SODIUM RESULTS. THE DIFFERENCES IN SODIUM VALUES COULD ALSO BE ATTRIBUTED TO THE DIFFERENCE IN METHODOLOGIES USED FOR THE TWO INSTRUMENTS, DIRECT VS. INDIRECT. BLOOD GAS USES A DIRECT METHOD WHEREAS THE CHEMISTRY SYSTEM USES AN INDIRECT METHOD. IT IS IMPORTANT TO NOTE THAT SIEMENS DOES NOT CLAIM SODIUM CORRELATION BETWEEN BLOOD GAS ANALYZERS AND CHEMISTRY ANALYZERS. REGRETFULLY, NOT BEING ABLE TO OBTAIN ANY ADDITIONAL INFORMATION FROM THE HOSPITAL, PREVENTS THE MANUFACTURER FROM INVESTIGATING THIS EVENT ANY FURTHER TO DETERMINE THE ACTUAL CAUSE FOR THE DIFFERENCES IN THE SODIUM RESULTS.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THE PATIENT PRESENTED IN CARDIAC ARREST AND HAD A PAST MEDICAL HISTORY OF WOLF- PARKINSON-WHITE SYNDROME FOR WHICH SHE WAS PRESCRIBED FLECAINIDE. CUSTOMER PRESUMED THE PATIENT'S CARDIAC ARREST WAS DUE TO AN OVERDOSE. CUSTOMER REPORTED THAT ABGS SHOWED HYPERNATRAEMIA, HOWEVER THE LAB SODIUM (NA+) RESULTS WERE FOUND TO BE NORMAL (TIMING AND RESULTS ARE UNDER INVESTIGATION). CUSTOMER INDICATED THAT THE PATIENT WAS TREATED WITH CPR, INTRALIPID AND ADRENALINE INFUSION. CUSTOMER REPORTED THAT OUTPUT RESTORED ON HIGH DOSE ADRENALINE AFTER ABOUT 45 MINUTES. CUSTOMER INDICATED THAT AFTER LAB NA+ RESULTS WERE REPORTED AS NORMAL, SODIUM BICARBONATE WAS GIVEN WITH VISIBLE NARROWING OF THE QRS COMPLEXES. CUSTOMER INDICATED CARDIAC ARREST AGAIN (VF RESISTANT TO SHOCKS) AND THE PATIENT DIED. IT IS UNCLEAR AT THIS TIME IF OTHER LABORATORY TEST RESULTS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280919 RAPIDPOINT 500 RP 500 JGS SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death