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

Model Number 6023006700

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2021

Event Type  malfunction  

Event Description

Patient was running on machine for 3.5 hours when the general safety which flashes with red started alarming.Machine was shut off.Manual rinseback was given with no problems.Patient chose just to get off at this time.Unit was showing a general failure.Manufacturer response for hemodialysis, (brand not provided) (per site reporter).Update software.

• 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: 12352888
• MDR Text Key: 267649416
• Report Number: 12352888
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6023006700
• Device Catalogue Number: 103453
• 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: 07/30/2021
• Date Report to Manufacturer: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1