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

Model Number PHOENIX

Device Problems Device Alarm System (1012); Device Contamination with Body Fluid (2317); Filtration Problem (2941)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Writer was taking off the patient, holding needle sites. Auto empty was completed. Blue hanson was removed and writer thought the dialysate looked dark. Writer asked for help from another nurse as one hand was holding sticks. Nurse came to help and she removed the red hanson from the dialyzer and also thought it looked dark. Writer called over the charge nurse to test for blood in dialysate. Both hansons tested positive along with the drain hose. Machine was removed and biomed called. Manufacturer response for hemodialysis unit, (brand not provided) (per site reporter). After the patient incident. The unit was brought back to the biomed work area. Once back there; i completed a patient simulation. During the patient simulation, i observed the bld value (page 2 of the status screen). The range is supposed to be between 190 and 200. During the simulation the range was 188, 189, and occasionally it obtained 190. In the back of the bld sensor there is the pushrod that simulates blood in dialysate. When i pushed the rod in. The value dropped as it should--down to 92. And the blood in dialysate alarm tripped in the 105 to 109 range. According to baxter-that is right in the range of when it should trip. By pushing in the rod and having the unit trip the "bld in dialystate alarm" as it should. This eliminates the possibility that the protective circuit board is bad. As stated above i contacted baxter. They agreed with me, stating that the unit should've tripped the blood in dialysate error, especially with the fact that there was blood in both the red and blue hoses for the dialyzer. Additionally, there was red/blood detected even at the output drain of the phoenix. They agreed with my recommendation that the bld sensor should be replaced. They also stated that no further component replacement was necessary. Because everything besides the bld sensor worked. I replace the bld sensor. No calibration was required as stated in the service manual. Because the sensor calibrates itself every time the t1 tests are completed. After this i ran a setup with a pa and puf auto cal. Performed a patient simulation for 30 minutes. Unit passed. Total amount removed according to unit: 800 ml-- measured amount 814. 7 ml (within 25ml +/-) completed a bleach/rinse. Unit returned to service.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11817166
• MDR Text Key: 250377828
• Report Number: 11817166
• 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: 04/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 04/15/2021
• Device Age: 9 YR
• Event Location: No Information
• Date Report to Manufacturer: 05/13/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown