ACCURA HEMOFILTRATION SYSTEM
Received May 19, 2008 · Event occurred Apr 21, 2008
Report 1423500-2008-00374 · MDR key 1048085
Device
Product problems
- Output, high
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A BIOMED AT THE FACILITY CALLED BAXTER TECHNICAL SERVICE REGARDING AN ACCURA HEMODIALYSIS INSTRUMENT. THE INSTRUMENT IS REMOVING TOO MUCH FLUID. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND DETERMINED THE SCALES WERE OUT OF CALIBRATION. THE FSE CALIBRATED BOTH SCALES. MACHINE WAS TESTED ACCORDING TO THE ACCURA DATA TEST SHEET. NO OTHER PROBLEMS WERE NOTED. THE INSTRUMENT IS FULLY FUNCTIONAL. A FOLLOW UP CALL WAS PLACED TO THE FACILITY BY BAXTER CORPORATE PRODUCT SURVEILLANCE. THE BIOMED WAS ASKED IF THIS INCIDENT OCCURRED DURING PT USE. HE STATED A MEASUREMENT WAS TAKEN AFTER THE PT TREATMENT. HE ALSO STATED THAT HE DID NOT HAVE ANY DETAILS ABOUT THE INCIDENT OTHER THAN THERE WAS NO PT INJURY AND NO MEDICAL INTERVENTION. THE BIOMED WAS UNABLE TO PROVIDE FURTHER DETAILS. THE BIOMED ALSO WAS UNABLE TO IDENTIFY A CLINICAL CONTACT. NO FURTHER INFO WAS ABLE TO BE OBTAINED.