BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDLAB 1245

    MDR report key: 3010197 · Received March 8, 2013

    Report

    Report Number
    1217157-2013-00034
    Event Type
    Death
    Date Received
    March 8, 2013
    Date of Event
    October 6, 2012
    Report Date
    March 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS INVESTIGATED THIS ISSUE AND HAS DETERMINED THE FOLLOWING: ALTHOUGH THIS EVENT OCCURRED IN (B)(6) 2012 THE CUSTOMER DID NOT NOTIFY SIEMENS OF THIS INCIDENT UNTIL (B)(6) 2013. THE CUSTOMER HAS TWO OPERATIONAL BLOOD GAS ANALYZERS ON THE SAME FLOOR IN ADDITION TO THE ANALYZER THAT WAS EXECUTING A WASH CYCLE. THE CUSTOMER DID NOT PROVIDE A REASON FOR NOT ANALYZING THE BLOOD SAMPLES TAKEN AT 8:32 AM AND 8:36 AM ON (B)(6) 2012 ON EITHER OF THESE TWO ANALYZERS. THE CUSTOMER HAS NOT PROVIDED ANY TEST RESULTS EXCEPT FOR THE PH RESULT OF 6.33, WHICH IS AFTER THE CHILD WAS BORN. THE SERVICE HISTORY FOR THE THREE BLOOD GAS ANALYZERS AT THIS CUSTOMER SITE HAS BEEN REVIEWED BY SIEMENS AND THE DATA SHOWS THAT THE ANALYZERS WERE OPERATING AS INTENDED IN THE (B)(4) 2013 TIME FRAME. THE CUSTOMER HAS NOT REPORTED OR SUGGESTED THAT THE ANALYZER MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER AT A (B)(6) HEALTHCARE FACILITY REPORTED THAT TWO BLOOD SAMPLES WERE TAKEN FROM THE SAME FETUS, ONE SAMPLE AT 8:32 AM AND A SECOND SAMPLE AT 8:36 AM ON (B)(6) 2012. THE CUSTOMER INDICATED THAT THESE TWO SAMPLES WERE NOT ANALYZED ON THE RL1245 BLOOD GAS ANALYZER BECAUSE IT WAS EXECUTING A WASH CYCLE. THE HEART RATE OF THE MOTHER AND FETUS WERE ALSO BEING MONITORED. THE CUSTOMER INDICATED THAT THE HEART RATE OF THE MOTHER WAS MISTAKEN FOR THE HEART RATE OF THE FETUS. THE CUSTOMER REPORTED THAT AS A RESULT, IT WAS INTERPRETED BY THE DELIVERY TEAM THAT THE CONDITION OF THE FETUS HAD IMPROVED AND NO FURTHER ACTION WAS TAKEN. AT 9:32 AM, A CESAREAN SECTION WAS PERFORMED AND THE NEWBORN CHILD WAS DETERMINED TO BE HEAVILY ACIDOTIC (PH 6.33). TWO DAYS LATER, THE CHILD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100727 RAPIDLAB 1245 RAPIDLAB 1245 CHL SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD RL1245

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Death