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

Catalog Number 114748M

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Local Reaction (2035)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after 30 minutes of starting treatment with a revaclear 300, the patient experienced pruritus on the hands and feet, with a localized rash.It was further reported this was the first treatment used with this dialyzer.Medical intervention consisted of dexamethasone 5mg intravenously.Subsequently, the dialyzer was replaced.No additional information is available.

Manufacturer Narrative

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: REVACLEAR
• 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 - OPELIKA; 1101 jeter ave; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17253158
• MDR Text Key: 318349402
• Report Number: 3006552611-2023-00031
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414126216
• UDI-Public: (01)07332414126216
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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: 114748M
• Device Lot Number: C622315707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/02/2023
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female