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

Lot Number 69305H01

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fall (1848); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nausea (1970); Vomiting (2144); Convulsion/Seizure (4406); Syncope/Fainting (4411); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

A hemodialysis (hd) patient (male) has been experiencing multiple allergic reactions of unknown origin at various levels of severity.The patient's hd nurse reported that the patient's reactions are very random occurring at various times including prior to hd treatment, during hd treatment, and post hd treatments, including reactions at the patient's home and on days the patient did not receive hd treatments.The reactions include the following symptoms at various times and degrees: welts/hives/rash all over body, itching, lips and facial swelling, raspy voice, nausea and vomiting, unstable blood pressure or drop in blood pressure, convulsions, and normal saline -boluses in the presence of fluid overloaded.In addition, it was reported that the worst symptoms include convulsions, and/or the patient will "just pass out", including one time when the patient fell out of his wheelchair {date unknown).The patient was hospitalized from (b)(6) 2017 related to the multiple allergic reactions.When the patient returned to the clinic for hd treatment (after hospitalization) the dialyzer was changed to the revaclear dialyzer; a baxter product.However, the hd nurse reports that the patient continues to have all the same reactions with the revaclear dialyzer.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO
• MDR Report Key: 17528941
• MDR Text Key: 321144225
• Report Number: MW5135870
• 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: 04/17/2017

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
• Device Lot Number: 69305H01
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1