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

Catalog Number 103453

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the patient experienced a cardiac arrest while undergoing treatment with a phoenix dialysis machine. The cause of the event was not reported. Treatment was not reported. At the time of this report the patient outcome was not reported. No additional information is available.

Manufacturer Narrative

The device was evaluated on site. The phoenix device received functional testing. The device passed functional testing and no issues were found. No previous alarms were found. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. The reported issue was not verified. The cause of the condition could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this serial number. A device history review revealed no issues that could have caused or contributed to the reported issue. No device failure or malfunction was identified that could have caused or contributed to the reported event; therefore, the phoenix device is no longer considered suspect product in this event. 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: 8526849
• Report Number: 9616240-2019-00003
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414042035
• UDI-Public: (01)07332414042035
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/18/2019,05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2019
• Distributor Facility Aware Date: 03/25/2019
• Event Location: Other
• Date Report to Manufacturer: 04/18/2019
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Other