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

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Rn was unable to turn up the pump speed after the patient started his dialysis treatment.The (+) button would not work.Rinseback was given to the patient, and treatment was restarted on a new machine.Work order placed.

• 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: 14944374
• MDR Text Key: 295411967
• Report Number: 14944374
• 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: 03/03/2022

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 Operator: Health Professional
• 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: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1