BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABL77 BLOOD GAS AND ELECTROLYTE ANALYZER

    MDR report key: 2630632 · Received June 22, 2012

    Report

    Report Number
    2027541-2012-00034
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    May 29, 2012
    Report Date
    June 4, 2012
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K994346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT, CALIBRATION AND MANUAL QC LOGS WERE PROVIDED BY THE CUSTOMER FROM THE SUBJECT ABL77 ANALYZER. DATA FROM THESE LOGS DOCUMENTED THE FOLLOWING: CALIBRATION RECORDS SHOWED A PROPERLY FUNCTIONING ANALYZER, WELL WITHIN MANUFACTURER SPECIFICATIONS. MANUAL QC RECORDS SHOWED A HISTORY OF PERIODIC FAILURES OVER THE PAST COUPLE OF YEARS. A QC SAMPLE WAS PERFORMED ON THE MORNING OF THE INITIAL DATE IN QUESTION ((B)(4) 2012) WHICH WAS WITHIN MANUFACTURER SPECIFICATIONS. PATIENT RECORDS INCLUDED THE REPORTED SAMPLE ON (B)(4) 2012 AT 14:40 WITH A PH OF 6.77. THIS SAMPLE DID NOT INCLUDE A RESULT FOR PCO2 BECAUSE THE VALUE WAS OUTSIDE THE MEASURING RANGE. THE PATIENT LOT INCLUDED SAMPLE RESULTS FROM (B)(4) 2012. THE SUBJECT SAMPLE RESULT APPEARS INCONSISTENT WITH THE OTHER SAMPLES RESULTS IN THIS LOG. THE LOG DID NOT CONTAIN A RECORD OF THE SECOND REPORTED LOW PH RESULT. ARRANGEMENTS ARE IN PROCESS TO HAVE THE ABL77 ANALYZER RETURNED FOR FURTHER FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    A SCALP PH SAMPLE WAS OBTAINED FROM AN UNBORN NEONATE AND ANALYZED IN AN ABL77 BLOOD GAS ANALYZER. THE PH RESULT WAS REPORTED AS 6.77. BASED ON THIS RESULT, A C-SECTION WAS PERFORMED. DURING THIS PROCEDURE A SECOND BLOOD SAMPLE WAS COLLECTED AND ANALYZED USING A ROCHE BLOOD GAS ANALYZER WHICH REPORTED A PH OF 7.23. THE PHYSICIAN COMPLAINED THAT THE C-SECTION PROCEDURE WAS PERFORMED UNNECESSARILY. ON (B)(6) 2012, WE WERE INFORMED OF A SECOND INCIDENT USING THE SAME ANALYZER WHERE A C-SECTION WAS PERFORMED BASED ON A LOW PH VALUE FROM THE ANALYZER. THE ANALYZER IS NO LONGER IN USE AT THE CUSTOMER SITE. THERE WERE NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THESE C-SECTION PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL77 BLOOD GAS AND ELECTROLYTE ANALYZER ABL77 BLOOD GAS AND ELECTROLYTE ANALYZER CHL SENDX MEDICAL, INC. 391-866

    Patients

    Seq Age Sex Outcome Treatment
    1