ACCURA HEMOFILTRATION SYSTEM
Received Nov 27, 2007 · Event occurred Oct 29, 2007
Report 1423500-2007-01233 · MDR key 958292
Product problems
- Output, high
- Replace
Patient
UNK YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AN ACCURA DEVICE,THAT REMOVED TOO MUCH FLUID DURING A TREATMENT. THE PATIENT HAD TO BE REMOVED FROM THE DEVICE AND BE PLACED ON ANOTHER UNIT FOR THERAPY. NO PATIENT INJURY WAS REPORTED AT THE TIME OF THE INITIAL CALL. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT, BUT ALL WERE UNSUCCESSFUL.
Additional Manufacturer Narrative
EVALUATION SUMMARY: A FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE ON SITE IN 2007 AND FOUND NO PROBLEMS. THE FSE MADE NO ADJUSTMENTS TO THE DEVICE. THE VOLTAGES, PRESSURES, PUMP DELIVERY RATES, SCALES, BLOOD LEAK DETECTOR, TEMPERATURE, AIR DETECTOR, AND VENOUS LINE CLAMP WERE TESTED AND NO PROBLEMS WERE FOUND. A SIMULATED PATIENT TREATMENT WAS DONE USING A FILTRATE COLLECTION OF 2050ML. THE ACTUAL COLLECTION WAS 2057ML, WHICH IS WITHIN ACCEPTABLE ACCURACY LIMITS. NO PROBLEMS WERE NOTED DURING THE EVALUATION.