MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER 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 Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6). Should additional information become available, a supplemental report will be submitted.

Event Description

It was reported that 30 minutes after treatment with a revaclear 400/apac, the patient experienced chest tightness, coughing and difficulty breathing, associated with fever, sweating, and low blood pressure. Treatment was immediately stopped and dexamethasone 5 mg was administered intravenously. The clinical symptoms was reportedly improved. The dialyzer was replaced with an unspecified type of dialyzer. 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.

Manufacturer Narrative

Additional information was corrected from malfunction to serious injury event. 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 - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7864763
• MDR Text Key: 119835249
• Report Number: 9611369-2018-00101
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 114749
• Device Lot Number: 7-7200-H-01
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/11/2018 Patient Sequence Number: 1