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

Model Number PHOENIX

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

Patient was running on machine.Venous pressure kept dropping to 0.Diaphragm neutral positions was completed times 2.It would work for about 10 min then it would quit.Bio med was called and stated it could be the chamber in the tubing.Patient was rinsed back.During descale sounded like the pump would not kick in and it was not turning.Did put machine in a rinse.Rinsed with no issues.Machine was then set up with new tubing, calibrated with no problems all alarms passed.Patient was able to finish run on the machine with not problems.When putting machine into descale again, i and another nurse, the pump did not start again with the descale and venous pressures remained high.Called and updated bio med.Pa was also aware of machine problems with patient.Manufacturer response for hemodialysis, baxter (per site reporter).Internal.I called baxter and discussed the incident again to find a preventable solution.His analysis is the hose holding the connector had just over time after being exposed to heat, chemicals and age (unit 8 years old), lost some of its elasticity and was a little brittle and the connector slid back over time and use.I asked if a one-time inspection on all machines was necessary and he stated not at this time since it was such an isolated incident and not 100% proven to be the cause of the incident.I stated i would add it to my personnel checklist to look at and check during up coming p.M.¿s, he said that would be a good idea.At this time, baxter is not looking to study this as a problem as in the past like the transducers and other continuous issues.

• 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: 16409614
• MDR Text Key: 309898035
• Report Number: 16409614
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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: 10/28/2022
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Male