MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a leak and smoke were observed from the back of a phoenix dialysis machine.This was noticed when powering up the machine.There was no patient involvement.The machine remained in clinical use after the event with no further issues reported.Additional information was requested, but is not available at this time.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be performed.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; medolla modena
• MDR Report Key: 7427204
• MDR Text Key: 105692260
• Report Number: 9616240-2018-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K103832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/12/2018,06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 103453
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2018
• Distributor Facility Aware Date: 03/15/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/12/2018
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1