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

Catalog Number 112016

Device Problem Disconnection (1171)

Patient Problems Air Embolism (1697); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

It was reported that the access line of the oxiris set got disconnected between the access line and the stopcock.An air in blood alarm was issued, however, no disconnection alarm was triggered.The lines were quickly clamped.Blood was found in the patient's bed.The extracorporeal blood was not returned.The total blood loss was estimated to be 233 ml.As a result of this incident, the patient received a blood transfusion, a bolus of 1liter of saline, a thoracic scan was performed and the patient was placed in a hyperbaric chamber to treat air embolism.The patient outcome was not reported.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy, with an oxiris set, there was a disconnected from the return line.It was reported that the patient lost an estimated 233 ml of blood.There was no 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 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10387897
• MDR Text Key: 221490602
• Report Number: 8010182-2020-00127
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 112016
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention