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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION BAXTER PHOENIX DIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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).
 
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Brand NameBAXTER PHOENIX DIALYSIS MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key13782761
MDR Text Key287326425
Report NumberMW5108168
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPHOENIX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2022 Patient Sequence Number: 1
Treatment
FERSENIUS CRIT LINE ADAPTER; GAMBRO CARTRIDGE BLOOD SET
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