MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PHOENIX

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/05/2022

Event Type  malfunction  

Event Description

Patient was on dialysis machine for a total of 20 minutes, concentrate type error 40 kept alarming and dialysis machine was not dialyzing properly.This writer changes the acid wand out for the acid jug twice with no new result and attempted to re-cal machine but there was no re-cal button available during this alarm.Patient was switched to new machine for proper dialysis and work order sent to biomed and machine pulled.Manufacturer response for hemodialysis, (brand not provided) (per site reporter): agreed with repair plan.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15064986
• MDR Text Key: 296227340
• Report Number: 15064986
• 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: 04/07/2022

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: 04/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Female