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

Catalog Number 103453

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported this event to the fda through medwatch: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a phoenix machine, a patient experienced a high ultrafiltration.It was reported that the patient's post weight was about 2.9 kg lower than the pre weight.The customer stated that the net ultrafiltration (uf) removed was 1.09l during dialysis.It was reported that the hemodialysis (hd) machine was showing d1-d2 error messages, reset the hd machine was performed and the d1-d2 error messages stopped showing.It was reported that in the last 45 minutes, d1-d2 error messages kept showing again and approximately 30 minutes remaining for treatment, the venous pressure went up to "300s".The customer decided to stop hd in order to prevent bloodline clotting and blood was returned to the patient.It was reported that the patient felt dry, however, their blood pressure was 129/73 mmhg.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation; therefore, a device analysis could not be completed.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 12338169
• MDR Text Key: 267131920
• Report Number: 9616240-2021-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414042035
• UDI-Public: (01)07332414042035(21)
• 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
• Report Date: 09/29/2021

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
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 60