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

Catalog Number 955503

Device Problems Disconnection (1171); Air/Gas in Device (4062)

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

Event Type  malfunction  

Manufacturer Narrative

The event was reported to have occurred (b)(6) 2022. Oxiris 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. The device was not received for evaluation however, photos were provided. Visual inspection observed air bubbles in the replacement and dialysate lines. 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.

Event Description

It was reported that during treatment with a prismaflex control unit and an oxiris set, a lot of air was observed in the set due to a sudden detachment of the screw end at the connection between the fluid bag and the set. The set was replaced. The event occurred twice and in both instances, the extracorporeal blood was not returned to the patient. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

• Brand Name: OXIRIS
• 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: 13892692
• MDR Text Key: 288669678
• Report Number: 8010182-2022-00077
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955503
• Device Lot Number: 21H2901A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2022
• 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 Treatment Data

Date Received: 03/24/2022 Patient Sequence Number: 1

Treatment

PHOXILIUM.; PRISM0CAL.; REGIOCIT.