MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114748

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

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Dyspnea (1816)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient experienced an allergic reaction within 60 minutes of starting treatment with a revaclear 300 dialyzer.The patient experienced chest distress, dyspnea and abdominal pain.The treatment was stopped immediately oxygen was administered.The patient was also treated with intravenous dexamethasone 5 mg, slow intravenous drip with 5mg nitroglycerin.Thirty minutes later, the patient's symptoms improved and a new dialyzer (no details provided) was used to continue the treatment.The patient was reported to be in a stable condition.No additional information is available.

Manufacturer Narrative

Additional information added to adverse event problem.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 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8793715
• MDR Text Key: 151133922
• Report Number: 9611369-2019-00093
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114947
• UDI-Public: (01)07332414114947
• 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
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 114748
• Device Lot Number: 8-9633-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR