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 01/31/2022

Event Type  malfunction  

Event Description

During patient¿s dialysis run, his dialysis machine had errors 65 dialysate line connector error, and 14 pressure or flow error.Errors were unable to be cleared and persisted.Patient was placed in rinseback and taken off of malfunctioning machine and a new machine was set up.Machine was pulled from the floor.Biomed notified.Manufacturer response for hemodialysis machine, (brand not provided) (per site reporter).Agreed with repair progress.

• 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: 14135055
• MDR Text Key: 289447584
• Report Number: 14135055
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 02/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1