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

Catalog Number 103453

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Vomiting (2144); Hematemesis (4478)

Event Date 02/05/2022

Event Type  malfunction  

Manufacturer Narrative

This event was reported to the fda through medwatch: mw5108168. 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 hypotension, dizziness, leg cramps, tachycardia and hematemesis. One hour to the end of treatment, the arterial line above the dialyzer and critline adapter was observed to be kinked. The line was manually unkinked and taped to ensure patency. The patient became hypotensive, dizzy, slightly tachycardic with complaints of leg cramps. The emergency medical services (ems) was called and by the time ems was finished with their evaluation, the patient experienced hematemesis. The patient was transferred to the emergency room (er) by ambulance and subsequently passed away at an unreported time. The cause of death or if an autopsy was performed was not reported. No additional information is available.

• Brand Name: PHOENIX MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14219832
• MDR Text Key: 290168608
• Report Number: 9616240-2022-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/27/2022 Patient Sequence Number: 1