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

Catalog Number 112016

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Diminished Pulse Pressure (2606)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Oxiris has been temporarily approved for use in the us under emergency use authorization (b)(4) with a specific indication to treat patients with covid-19 infection.Reporter: address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that five minutes into treatment with a prismaflex oxiris set, a patient experienced confusion, hypotension (with difficulty to measure blood pressure, therefore reading not reported) and a "discrete" pulse rate.Treatment was terminated and restarted using a prismaflex m100 set wih no further problems observed.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation but could not be analyzed because the serological status of the patient was not provided.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX OXIRIS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10563008
• MDR Text Key: 207830132
• Report Number: 8010182-2020-00183
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414012236
• UDI-Public: (01)07332414012236
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 112016
• Device Lot Number: 20E0202A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention