• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PHOENIX X36 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION PHOENIX X36 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number X36
Device Problems Leak/Splash (1354); Smoking (1585)
Patient Problem Respiratory Distress (2045)
Event Date 11/28/2017
Event Type  malfunction  
Event Description
Patient was undergoing dialysis when black smoke began to come from back of dialysis machine. No flame or spark was seen and no heat was appreciated from hd nurse. Patient's blood was rinsed back from the machine and he was disconnected, moved to another room and reconnected to a new dialysis machine. No obvious physical patient harm was seen and patient had cbc drawn later to monitor for heat induced hemolysis, which was normal. He was transferred to another room to complete his dialysis. A total of 7 staff on the unit were exposed to smoke and went to the ed for smoke inhalation and were treated with breathing treatments. Per review of biomed- the fluid line can sometimes leak due to weakening connectors and there is a solenoid (electrical switch) directly below the line. The solenoid was leaked on, creating a great deal of noxious electrical smoke. The company rep has been notified and recommendations from our biomed department have been given to the company for consideration.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHOENIX X36
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois
route 120
round lake IL 60073
MDR Report Key7145469
MDR Text Key95728184
Report Number7145469
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX36
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2017
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer12/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/26/2017 Patient Sequence Number: 1
-
-