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

Model Number PHOENIX

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Vomiting (2144); Dizziness (2194); Hematemesis (4478); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/05/2022

Event Type  Death  

Event Description

With one hour left of dialysis it was discovered by pod staff that the arterial line above the dialyzer and critline adapter was kinked.The line was manually un-kinked and taped in place to ensure patency.Pt became hypotensive c/o of dizziness and leg cramps.Pt was also slightly tachycardic.Pt continued to feel worse and ems was called.By the time ems had finished evaluation pt was vomiting with blood in the emesis.Pt was unable to ambulate with normal strength and was transferred to stretcher with help of 2 staff.Family was informed along with providers and management.Pt was transferred to the er by ambulance.Pt later died.Hct, mch, mchc =unable to report due to unknown interfering substances.Fda safety report id# (b)(4).

• Brand Name: BAXTER PHOENIX DIALYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13782761
• MDR Text Key: 287326425
• Report Number: MW5108168
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHOENIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FERSENIUS CRIT LINE ADAPTER; GAMBRO CARTRIDGE BLOOD SET
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Hispanic