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

Catalog Number 955503

Device Problem Filtration Problem (2941)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during continuous veno-venous hemodiafiltration (cvvhdf) with prismaflex oxiris sets, clotting was observed.The patient was treated with six oxiris sets over a 10-day period.The treatments were initially performed using regional citrate anticoagulation and were subsequently switched to heparin.Transmembrane pressure (tmp) too high alarms were generated, and large clots were observed in the oxiris sets.The extracorporeal (ec) blood was not returned to the patient; however, the patient did not present with any clinical symptom and no medical intervention was associated with this event.It was reported the patient was not acidotic or septic when the last couple of filter sets were used.At the time of this report, the patient¿s blood was stable.No additional information is available.

Manufacturer Narrative

The events occurred between (b)(6) 2022 and (b)(6) 2022.Oxiris s has been temporarily approved for use in the us under emergency use authorization eua(b)(4) 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

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation however, two companion samples were evaluated.A visual inspection and a pressure test was performed, no leaks were detected.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: OXIRIS S
• 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: 14024829
• MDR Text Key: 288787053
• Report Number: 8010182-2022-00090
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955503
• Device Lot Number: 20E0803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• 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 ST150 SET
• Patient Age: 59 YR
• Patient Sex: Male