MAUDE Adverse Event Report: BAXTER REVACLEAR, EXELTRA X2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Type  Injury  

Event Description

A hemodialysis (hd) patient (female) who had been admitted to the hospital for shortness of breath, heart issues, diabetes, leg wound and fluid overload, experienced multiple reactions during hemodialysis (hd) initially thought related to the dialyzer.The hospital's acute dialysis manager reported the patient experienced hypotension, dizziness, and shortness of breath shortly after initiation of the hd treatment using a revaclear dialyzer.Unspecified labs were drawn with results indicating a "type b dialyzer reaction".The dialyzer was changed with the same symptoms resulting.Subsequently, the dialyzer was reportedly changed again and the patient experienced the same symptoms.Reportedly, one each of the three treatments involved an exeltra dialyzer and one an optiflux dialyzer.During all three hd treatments, the patient was able to complete-treatments with unspecified medication and has been discharged from the hospital.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REVACLEAR, EXELTRA X2
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER
• MDR Report Key: 17535825
• MDR Text Key: 321050080
• Report Number: MW5142719
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1