OtherGIO
CAPILLIARY TUBES FOR ABL5 BLOODGAS ANALYZER
Received Mar 22, 2006 · Event occurred Feb 17, 2006
Report 3002807968-2006-00020 · MDR key 692773
Product problems
- Bubble(s)
- Inadequacy of Device Shape and/or Size
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER HAS OBSERVED SMALL BOBBLES OF AIR IN THE MEASURING CHAMBER OF THEIR ABL5, BLOODGAS ANALYZER AND SOMETIMES THE MEASUREMENT OF THE P02 VALUE IS TO HIGH, IN RELATION TO WHAT WAS EXPECTED. THE CUSTOMER USED A WROONG SIZE OF CAPILLARY TUBES. THE ANALYZER REQUIRES A MINIMUM OF 85 UL TO PERFORM A CORRECT MEASUREMENT OF ALL PARAMETERS. IF THE USER ONLY PROVIDES 55 UL THE ANALYZER WILL NOT GET ENOUGH BLOOD TO ENSURE CORRECT MEASUREMENTS. THIS CAUSES THAT THE P02 VALUE WILL BE TO HIGH AND SOMETIMES CLOSE TO THE VALUE OF ATMOSPHERIC AIR.