BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDLAB 1265 BLOOD GAS ANALYZER

    MDR report key: 6461498 · Received April 5, 2017

    Report

    Report Number
    3002637618-2017-00061
    Event Type
    Death
    Date Received
    April 5, 2017
    Date of Event
    December 16, 2016
    Report Date
    April 5, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS ON 07 MAR 2017 AND ON 08 MAR 2017 A SIEMENS FIELD ENGINEER WAS DISPATCHED TO THE HOSPITAL. UPON ARRIVAL HE FOUND THAT THE RL1265 WAS OPERATIONAL. HE REPLACED THE COOX MODULE COMPONENTS AND SENT THEM TO SIEMENS FOR EVALUATION. AFTER THE COMPONENTS WERE REPLACED, HE RAN A QC AND IT PASSED. HE ALSO PROCESSED SEVERAL PATIENT SAMPLES WITHOUT ERRORS. THE INSTRUMENT WAS FULLY OPERATIONAL. A VISUAL INSPECTION OF THE RETURNED COOX MODULE COMPONENTS INDICATED THAT THERE WERE NO ISSUES. THE COOX MODULE WAS INSTALLED ON AN INTERNAL SIEMENS RAPIDLAB 1265 AND TESTED FOR FOUR DAYS. THE ASSEMBLY PERFORMED AS EXPECTED AND THERE WERE NO ISSUES WITH QC RECOVERIES OR BLOOD SPECIMENS. THE INSTRUMENT FILES THAT WERE PROVIDED TO SIEMENS DID NOT CORRELATE TO THE TIME THE EVENT OCCURRED SO THEY DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THEY WERE FOR THE TIME PERIOD BETWEEN 05 FEB 2017 AND 14 FEB 2017. INSTRUMENT DATA FILES FOR THE TIME OF THE EVENT (DECEMBER 2016) WERE NOT AVAILABLE. DISCUSSIONS WITH THE CUSTOMER INDICATE THAT THE PATIENT WAS DOING VERY POORLY AND NOT HAVING THB AVAILABLE ON THE RL1265 MADE NO DIFFERENCE TO THE OUTCOME OF THE PATIENT. THEY ALSO INDICATED THAT THE RL1265 DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. THEY GOT THB RESULTS FOR THE PATIENT EVERY HALF HOUR FROM THE LAB (ON A DIFFERENT ANALYZER). BASED ON SIEMENS INVESTIGATION INTO THIS EVENT AND THE INFORMATION SIEMENS WAS ABLE TO OBTAIN FROM THE CUSTOMER, THE INDICATION IS THAT THE RAPIDLAB 1265 INSTRUMENT WAS OPERATING AS INTENDED AND NO FURTHER INVESTIGATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THE RAPIDLAB 1265 (RL1265) INSTRUMENT REPORTED A D70_2 ERROR MESSAGE (SYSTEM FAILS A CO-OX OPTICAL CLARITY TEST) FOR THB. THE CUSTOMER THEN MENTIONED THAT A CASE IS IN THE CORONER'S COURT DUE TO THE THB BEING UNAVAILABLE, A PATIENT BLEED WAS MISSED. THE CUSTOMER INDICATED THAT THE PATIENT WAS DOING VERY POORLY AND NOT HAVING THB AVAILABLE ON THE RL1265 MADE NO DIFFERENCE TO THE OUTCOME OF THE PATIENT. THEY ALSO INDICATED THAT THE RL1265 DID NOT CAUSE OR CONTRIBUTED TO THE DEATH OF THE PATIENT. THEY GOT THB RESULTS FOR THE PATIENT EVERY HALF HOUR FROM THE LAB (ON A DIFFERENT ANALYZER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241970 RAPIDLAB 1265 BLOOD GAS ANALYZER RL 1265 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death