BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADAPTOR FOR ABL5

    MDR report key: 692855 · Received March 22, 2006

    Report

    Report Number
    3002807968-2006-00019
    Event Type
    Other
    Date Received
    March 22, 2006
    Date of Event
    February 17, 2006
    Report Date
    March 22, 2006
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A BLOOD GAS ANALYZER (ABL5), REPORTED A WRONG P02 MEASUREMENT, I.E. AS BEING CLOSE TO ATMOSPHERIC AIR, IN RELATION TO WHAT WAS EXPECTED. IN ORDER TO USE CAPILLARY TUBES (TRADE NAME CLINITUBES) AS SAMPLE HOLDERS TO ABL5, AN ADAPTER ALSO FUNCTIONS AS A CLOT CATCHER. THE USER HAS MISTAKENLY MIXED THREE DIFFERENT LOTS OF ADAPTERS. ONE OF THESE LOTS MIGHT BE A DEFECT LOT THT HAS PREVIOUSLY BEEN RECALLED BY FAN 915-203. DUE TO A PRODUCTION DEVIATION AT THAT TIME THE DIMENSIONS AND SHAPE OF THE CAPILLRY ADAPTOR FOR ABL5/BPH5 DID NOT FIT CORRECTLY TO THE CLINITUBES AND THE ABL PROBE. THEREFORE THE ADAPTORS COULD DRAW AIR INTO THE MEASURING CHAMBER. THIS HAS ALREADY BEEN CORRECTED THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTOR FOR ABL5 ADAPTOR FOR A BLOODGAS ANALYZER CHL RADIOMETER MEDICAL APS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *