ABL 800 FLEX
Received Jan 12, 2011 · Event occurred Nov 8, 2010
Report 3002807968-2011-00002 · MDR key 1993709
Device
Product problems
- Mechanical Problem
Patient
44 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
IT HAS NOT BEEN POSSIBLE TO OBTAIN THE FAILING MEMBRANES FOR INVESTIGATION. MEASURING RESULTS FOR THE ABL827 AND COMPARISON INSTRUMENT ARE NOT AVAILABLE FOR INVESTIGATION. CALIBRATION AND QC RESULTS WERE OK AT THE TIME OF MEASUREMENT, SO NO WARNINGS HAVE BEEN SHOWN ON MEASURING RESULTS. AFTER EXCHANGE OF THE NA AND REFERENCE MEMBRANES, THE RESPONSIBLE HEALTHCARE PROFESSIONAL NOW TRUSTS THE INSTRUMENT AGAIN. ROOT CAUSE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP OR FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN CONCLUDED.
Description of Event or Problem
TWO VENOUS SAMPLES WERE ANALYZED ON BOTH THE ABL827 IN ICU AND ON A LAB INSTRUMENT FOR COMPARISON. THE INSTRUMENT AT ICU SHOWED A 5-7 MM NEGATIVE BIAS RELATIVE TO THE LAB INSTRUMENT, SUPPOSEDLY DUE TO A FAILING MEMBRANE. IT IS LIKELY THAT PREVIOUS MEASURING RESULTS HAVE ALSO BEEN FALSELY LOW FOR THIS PARAMETER. NO INFO REGARDING THE PT'S STATE OR DIAGNOSIS PRIOR TO THE INCIDENT IS SO FAR AVAILABLE. THE PT WAS ADMINISTERED 7 L NACL 0,9%, AND FURTHERMORE 'ADDEX' SODIUM CHLORIDE AS SHE DID NOT RESPOND TO THE TREATMENT. TREATMENT WAS SOLELY BASED ON THE ANALYSIS RESULTS.