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

Catalog Number 955540

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

Patient Problems Cardiac Arrest (1762); Hemolysis (1886)

Event Date 09/21/2022

Event Type  Injury  

Event Description

It was reported that at an unknown time during continuous renal replacement therapy with a prismaflex oxiris set and a prismaflex control unit, reddish effluent was observed.No blood leak detection alarm was generated, and no effluent sampling was reported for confirmation of red blood cells.It was further reported the patient experienced hemolysis and cardiac arrest.It was reported the patient received continuous cardiac compression rescue.At the time of this report the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

(b)(6).Oxiris c is similar to oxiris and oxiris s.Oxiris and oxiris s have been temporarily approved for use in the us under emergency use authorization eua200164 with a specific indication to treat patients with covid-19 infection.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the actual sample was not available; however, photos of the sample were provided for evaluation.Visual inspection observed a red coloration in the effluent fluid.The reported condition was verified.The cause 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 lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: OXIRIS SET
• 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 - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15663171
• MDR Text Key: 302328892
• Report Number: 8010182-2022-00322
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124090
• UDI-Public: (01)07332414124090
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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: 01/31/2024
• Device Catalogue Number: 955540
• Device Lot Number: 22B0085
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male