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

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.

• Brand Name: PHOENIX X36
• Type of Device: DIALYZER, 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 Key: 7145469
• MDR Text Key: 95728184
• Report Number: 7145469
• 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: User Facility
• Reporter Occupation: Other
• 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 Received: 12/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: X36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other