MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 103453

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient passed away after being connected to a phoenix dialysis machine for four minutes.It was reported that the patient had just undergone an unspecified procedure prior to being connected.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

H10: the phoenix machine was internally inspected by the facility's biomedical engineer that confirmed that the machine performed according to all manufacturers¿ specification.A patient simulation was performed and the device passed.A few drops of dialysate fluid was observed to be coming out from the bicarbonate conductivity cell during the inspection and the biomedical engineer replaced both the acetate and bicarbonate conductivity cells and the safety valve.The device was returned to service.Based on technical analysis, no correlation exists between this little external leakage and a potential patient event because fluid drip from this component, that is outside the ultrafiltration and mass balance portion of the phoenix hydraulic circuit, can only lead to less bicarbonate fluid delivered and consequent low conductivity alarm.These findings, were discussed with a baxter technical service confirming that there wasn't the need to have a qualified baxter technician inspect the device.Based on additional information received, the phoenix machine was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: b1, h1.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11109129
• MDR Text Key: 224803120
• Report Number: 9616240-2020-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K070643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death