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

Model Number PHOENIX

Device Problems Connection Problem (2900); Infusion or Flow Problem (2964); Pressure Problem (3012); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

With 38 minutes left in patient¿s dialysis run, the dialysis machine started alarming with code 65 - dialysate connector line error.An attempt was made to clear the alarm by checking the seating of the dialysate line connectors.Alarm was still unable to be cleared and the machine was asking for a restart, followed by alarms 14 - pressure or flow error, 40 concentrate type error, and 44- dialysate flow.The patient was taken off of dialysis.A new machine set up was unavailable, as one of the spare machines was in a bleach disinfect, and the other spare machine had just been repaired today but needed to be cultured before use.Provider was notified by epic in basket.Patient left 0.8 kg over dry weight.No harm to patient was noted at this time.Manufacturer response for hemodialysis, (brand not provided) (per site reporter) tested cal on pi and po pressure transducer, between slave and hydraulic boards, 0 mmhg was 25 on hydraulic and 0 on slave on both.Replaced both pi and po pressure transducer with new ones and calibrated both.400mmhg+400mmhg on both.Ran patient sim without error.Called baxter and spoke with rep, she gave case number she said to return unit to use.Returned unit to use.

• 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: 16426532
• MDR Text Key: 310092831
• Report Number: 16426532
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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: 02/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1