MAUDE Adverse Event Report: GAMBRO DASCO SPA PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PHOENIX

Device Problem Defective Device (2588)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

This nurse was called into patient's station (in dialysis) by lpn due to an error code that was unable to be cleared.Machine was having a dialysate connector error , pressure flow error, and dialysate flow error.These alarms were unable to be cleared, set up was verified as correct.Patient was taken off of machine and new machine was set up for patient to finish his dialysis run.Patient was 2.5 hours into his run when error occurred.Was able to finish his dialysis on the second machine.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DASCO SPA; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15787760
• MDR Text Key: 303557016
• Report Number: 15787760
• 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: 08/05/2022

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: 08/05/2022
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 11/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1