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

Model Number 6023006700

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

Getting d1-d2 error message after 2 hours and 15 minutes of hemodialysis.Hemodialysis treatment terminated 15 minutes early per nurse practitioner.

• 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: 10042587
• MDR Text Key: 190501166
• Report Number: 10042587
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6023006700
• Device Catalogue Number: 103453
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2555 DA