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

Catalog Number	115269
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/04/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during continuous renal replacement therapy, a patient passed away while connected to a prismaflex control unit.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.
Additional Manufacturer Narrative
The actual device was inspected on-site by a qualified baxter technician and no issues were identified.A full technical check of the device was performed and the device was found to meet manufacturer's specifications.The machine was then calibrated and returned to clinical service.A device history review revealed no complaints associated with the device in the previous 24 months.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information added to f tab: importer/reporter number.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9889236
• Report Number: 9616026-2020-00012
• Device Sequence Number: 16651074
• Product Code: KDI
• UDI-Device Identifier: 07332414117702
• UDI-Public: (01)07332414117702
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2020
• Report Date (Section F): 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 115269
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 04/23/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/06/2020; 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 04/06/2020