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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NamePHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key11817166
MDR Text Key250377828
Report Number11817166
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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 Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPHOENIX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/15/2021
Device Age9 YR
Event Location No Information
Date Report to Manufacturer05/13/2021
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

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