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

Model Number PHOENIX

Device Problem Pumping Problem (3016)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Patient had 1 hour and 45 minutes left of dialysis treatment, machine alarmed for empty acid container acid and container full, attempted to adjust wand and new wand, machine was not pulling up the acid from jug into machine, several alarms continued.Rinseback given to patient and patient moved to new machine at this time to get correct dialysis.Manufacturer response for hemodiaylsis, (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.; 1101 jeter avenue; opelika AL 36801
• MDR Report Key: 15690394
• MDR Text Key: 302591943
• Report Number: 15690394
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• 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: 07/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1