MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PHOENIX

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/21/2023

Event Type  malfunction  

Event Description

Patient had weighed in at [redacted] kg prior to his dialysis treatment which is not unusual for him.Dry weight is 1.7 kg less.Patient was set to remove 1.8 kg to bring him to [weight redacted] kg on machine.Patient began cramping severely with 45 min of his treatment left.Also, during this time, dialysis machine was leaking heavily underneath.Patient's post weight was 2.6 kg lower than initial weight.Patient did weigh twice to verify weight.Hemodialysis machine stated that only 1.6 kg was removed.When setting up machine for next patient, saline drained out and machine alarmed blood sensed in venous line.Unable to put in recirculation.Questionable if machine affected prior patient's dialysis treatment.Provider was updated on patient's dialysis treatment and biomed was notified.Patient weighed different at beginning of treatment from end.Need unit inspected.Manufacturer response for hemodialysis, (brand not provided) (per site reporter).Initially ran unit in a rinse to find leak, found silicone elbow on pi transducer ripped and leaking, replaced elbow and leak was repaired.During rinse for leak check, i could hear the puf pump grinding.After leak repair, i replaced the puf pump (p/n sp00185).I also noticed bi-cart leaking from pb pump segment, segment was replaced and pb, pa was calibrated and also autocal diascan.I ran a patient simulation which also autocal's the puf pump for 30 minutes set at 800 for fluid removal.The first simulation was ran and 813 was removed verified by scale.Baxter was called and he recommended running another simulation.Simulation 2 was run, and fluid removal measured 806, both simulations were within 2% of set-up, unit specs are 5%.Mfr rep recommended returning it for use under baxter workorder.Unit was returned for use.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 17669212
• MDR Text Key: 322488636
• Report Number: 17669212
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PHOENIX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2023
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1