MalfunctionCCE
ABL700
Received Jul 17, 2006 · Event occurred Jun 16, 2006
Report 3002807968-2006-00036 · MDR key 743489
Device
Generic name
Blood Gas Analyzer
Manufacturer
Radiometer Medical ApsModel number
ABL735Catalog number
393-725
Lot number
*
Product problems
- Device Alarm System
- Low Test Results
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A TOO LOW NA-VALUE WAS MEASURED ON AN ABL735 BLOOD GAS ANALYZER. NO ALARM WAS ISSUED. THE LOW NA VALUE MAY HAVE BEEN CAUSED BY A DEFECTIVE REFERENCE ELECTRODE. ALLEGEDLY 4 OR 5 PATIENTS WERE INAPPROPRIATELY TREATED FOR TOO LOW NA VALUES IN THE BLOODSTREAM. NO SERIOUS INJURY OR DEATH HAS BEEN REPORTED AS A CONSEQUENCE OF THESE TREATMENTS.
Additional Manufacturer Narrative
THE HOSPITAL ALLEGES THE REFERENCE MEMBRANE IS DRIFTING AFTER 4 OR 5 DAYS. ADDITIONAL TESTS ARE UNDERTAKEN.