MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114749

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

Patient Problems Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that 20 minutes into treatment with a revaclear 400 dialyzer, the patient experienced chest pain, difficult y breathing, a drop in blood pressure, severe itching and diarrhea.Treatment for the event was not reported.The patient outcome was not reported.No additional information is available.

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.

• Brand Name: REVACLEAR 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12511760
• MDR Text Key: 272655240
• Report Number: 9611369-2021-00248
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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 Catalogue Number: 114749
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Other