MAUDE Adverse Event Report: GAMBRO AB PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PHOENIX

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Dizziness (2194)

Event Date 01/17/2020

Event Type  malfunction  

Event Description

Dialysis machine started having alarms while patient dialyzing.It started with concentrate type error, then had high venous pressure 155 and wanted a restart.Patient's venous pressures were within a normal range.A diaphragm neutral was performed.This seemed to correct things and the normal alarms you see when there's been a high pressure, like d1 flowmeter failure, diascan measurement failure and the alarms resolved only momentarily.Then alarm 116 dialyzer inlet pressure sensor alarm sounded as well as 134 temperature.From all the stopping an starting the dialyzer started to clot.I decided to take the patient off, no rinseback, new machine was set up.Patient was restarted on new machine.Patient had started to feel dizzy and was given 2l o2 nc.Patient felt better relatively quickly per herself.When trying to put this machine into a bleach at the end of the day it gave me alarm 65 dialysate line connection error.I re-seated the dialysate lines and got the same error code again.This machine was unable to be bleached and will have to be cultured before reuse.Biomed notified.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO AB; one baxter parkway; deerfield IL 60015
• MDR Report Key: 10017205
• MDR Text Key: 189612086
• Report Number: 10017205
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/10/2020,01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 03/10/2020
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1