BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOOD GAS ANALYZER

    MDR report key: 1379381 · Received December 8, 2005

    Report

    Report Number
    3002807968-2005-00014
    Event Type
    Other
    Date Received
    December 8, 2005
    Date of Event
    October 23, 2005
    Report Date
    December 5, 2005
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYMPTOMS ARE CONSISTENT WITH A COAGULATED BLOOD CLOT OBSTRUCTING THE PASSAGE OF THE BLOOD SAMPLE INTO THE ANALYZER - FROM A NEONATE. THIS BLOOD CLOT IN THE CAPILLARY MAY HAVE CAUSED THAT THE SAMPLE WERE NOT ASPIRATED INTO THE ANALYZER AT FIRST. BUT A VACUUM WERE CREATED IN THE ABL 735. A SUDDEN RELEASE OF THE CLOT MAY HAVE CAUSED A POOR LIQUID TRANSPORT ON THE ABL OF THE SAMPLE. ALSO IT MAY HAVE CAUSED A DILUTION OF THE SAMPLE. IT HAS NOT BEEN POSSIBLE TO GET ALL THE RELEVANT INFO FOR MAKING A CONCLUSION TO THIS CASE YET. THEREFORE, A FINAL REPORT WILL BE SEND WITHIN A MONTH.

    Description of Event or Problem · 1

    A NEONATE WAS INITIALLY TESTED TO HAVE A TOO HIGH BILIRUBIN VALUE (300 MMOL/L). WHEN THE NEONATE WAS TESTED AGAIN THE RESULT THIS TIME WAS 76 MMOL/L. THE DOCTOR IN CHARGE DECIDED THAT THE BILIRUBIN VALUE WAS TOO LOW COMPARED TO THE EARLIER VALUE. IN THE AFTERNOON THE SAME DAY A NEW SAMPLE FROM THE SAME CHILD WAS TESTED - THIS TIME, IT SHOWED THE VALUE 288 MMOL/L. THE DOCTOR TRUSTED THIS RESULT. WHEN THE ABL ANALYZER TESTED THE SAMPLE WITH THE TOO LOW RESULT, THE ABL 735 ERROR MESSAGES WERE GIVEN. FURTHERMORE QUESTION MARKS TO ALL PARAMETERS MEASURED IN THE PH/BG MODULE, AND TO PARAMETERS DEPENDENT ON THE REFERENCE ELECTRODE WERE GIVEN. IT IS BELIEVED THAT THE POOR SAMPLE TRANSPORT DID ALSO GIVE ERRONEOUS RESULTS FOR THE REST OF THE PARAMETERS MEASURED IN THE EL/MET MODULE AND OXI MODULE - AND THESE PARAMETERS WERE GIVEN WITHOUT QUESTION MARKS. IF THE LOW RESULT HAD BEEN TRUSTED, THE WORST CASE SCENARIO IS THAT THE CHILD COULD HAVE HAD A BRAIN DAMAGE - BUT THE LOW BILIRUBIN VALUE WAS INCONSISTENT WITH THE CLINICIANS EXPECTED PICTURE OF A POSSIBLE DECREASE IN BILIRUBIN OF THE NEONATE. NO OTHER DEVICE WAS INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GAS ANALYZER ABL700/ABL800 SERIES CHL RADIOMETER MEDICAL APS ABL 735

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other