Fmc Odyssey Dialysis

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 35949 Based on observation, interview, facility procedure review, and a manufacturer’s instructions for use (IFU) review, the facility failed to maintain the arterial drip chamber fluid levels at approximately 90% full and the venous drip chamber fluid levels at approximately 70% full during four of four observations. Failure to follow the manufacturer’s IFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 44 patients who received dialysis treatments at the facility. Findings include: A facility procedure titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” published 05/05/2025, indicated, “Final Machine Verification - Prior to starting the blood pump, verify the following: 1. All connections are secure. 2. Dialysate lines are attached properly to the dialyzer. 3. There is at least 300 ml [milliliters] of saline in the saline bag and the saline line is double clamped. 4. Any unused administration lines are clamped. 5. The arterial chamber is 85-95% full, and venous chamber is 65-75% full. 6. Arterial and venous monitoring transducers are securely connected, not wet with saline, and the transducer clamps are open. 7. Blood pump segment is threaded through the pump properly. 8. Venous drip chamber is correctly positioned in its housing and venous bloodline is threaded through the venous occluding clamp. 9. No kinks or bends are evident in any of the tubing. 10. No air is noted in the dialyzer or bloodlines.” The bloodline manufacturer’s IFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors,” with a copyright dated of 2024, indicated, “During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible separation or leaks. b. Do not allow the access or bloodline connections to be covered with a blanket or clothing during the treatment. c. Maintain fluid level in arterial chamber at approximately 90% full and venous chamber at approximately 70% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air leaks will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 06/12/2025 at 7:55 AM revealed the arterial drip chamber fluid levels were less than (<) 90% full in Stations 3, 5, 6, 8, 9, 10, 12, and 13, and the venous drip chamber fluid levels were greater than (>) 70% full in Stations 1, 2, 3, 5, 6, 7, 8, 9, 10, 12, and 13. Observation of the hemodialysis treatment area on 06/12/2025 at 8:35 AM revealed the arterial drip chamber fluid levels were < 90% full in Stations 3, 6, 8, 9, 10, 12, 13, and 15, and the venous drip chamber fluid levels were > 70% full in Stations 1, 2, 5, 6, 7, 8, 9, 10, 11, 12, and 13. Observation of the hemodialysis treatment area on 06/12/2025 at 8:55 AM revealed the arterial drip chamber fluid levels were < 90% full in Stations 3, 6, 8, 9, 12, 13, and 15, and the venous drip chamber fluid levels were > 70% full in Stations 1, 3, 5, 6, 7, 8, 9, 11, 12, 13, and 15. Observation of the hemodialysis treatment area on 06/12/2025 at 10:25 AM with the Clinical Manager (CM) revealed the arterial drip chamber fluid levels were < 90% full in Stations 3, 4, 6, 9, 10, 11, 13, 14, and 15, and the venous drip chamber fluid levels were > 70% full in Stations 4, 6, 9, 11, 14, and 15. During an interview on 06/12/2025 at 10:25 AM, the bloodline manufacturer’s IFU was reviewed with the CM, and the CM confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s IFU. During an interview on 06/12/2025 at 10:53 AM, the Medical Director confirmed the staff should “absolutely” follow the bloodline manufacturer’s IFU for the arterial and venous drip chamber fluid levels. During an interview on 06/12/2025 at 11:17 AM, Certified Clinical Hemodialysis Technician (CCHT) #1 stated the arterial drip chamber fluid levels should be “85%” full and the venous drip chamber fluid levels “not as full.” CCHT #1 confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s IFU. During an interview on 06/12/2025 at 11:47 AM, the Registered Nurse (RN) stated the arterial drip chamber fluid levels should be “90%” full, and the venous drip chamber fluid levels should be “70%” full. The RN confirmed he was trained and expected to follow the bloodline manufacturer’s IFU.”