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 Codes	Cardiopulmonary Arrest (1765); Death (1802)
Date of Event	12/16/2019
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 (crrt), the patient ¿coded¿ and 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.At the time of this report, no further details were provided regarding patient treatment or medical interventions.No additional information is available.
Additional Manufacturer Narrative
The device was evaluated onsite by a qualified baxter technician.A service history review revealed that no repetitive similar failure occurred, which indicates that any parts replaced during servicing did not cause or contribute to the reported event.An inspection of the machine did not identify any abnormalities that could have contributed to the reported condition.The device was inspected and returned to use.The baxter device is no longer a suspect in the reported death.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: 9569459
• Report Number: 9616026-2019-00065
• Device Sequence Number: 16897103
• Product Code: KDI
• UDI-Device Identifier: 07332414117702
• UDI-Public: (01)07332414117702
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/21/2020

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 Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/21/2020
• 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