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

Catalog Number 103453

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter alternate phone no: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient took a break to use the bathroom while performing dialysis on a phoenix device, and upon reconnection to the device, the patient coded.Resuscitation attempts by the medical team were unsuccessful.The patient passed away.The cause of death was not reported.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated on site by a baxter qualified technician who confirmed that the device was working according to specifications.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A short simulated therapy was successfully performed and no device malfunction was identified.Based on information from the device evaluation, the phoenix control unit was determined not to be a factor in the event of patient death.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15079682
• MDR Text Key: 296348198
• Report Number: 9616240-2022-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death