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

Catalog Number 955503

Device Problem Leak/Splash (1354)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Oxiris s 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 air was continuously coming out of the top of the filter of an prismaflex oxiris set.The set was reprimed four times and the event persisted.It was further reported that the user had selected prime test instead of reprime.Upon further observation, it was noted that the blue striped tubing coming from the top of the filter where the tubing was 'glued' into the connector that "screwed into the top of the filter" was leaking.There was no patient involvement.No additional information is available.

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; therefore, a device analysis could not be completed.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: 11415099
• MDR Text Key: 238359365
• Report Number: 8010182-2021-00088
• Device Sequence Number: 1
• Product Code: KDI
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 955503
• Device Lot Number: 20C3104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1