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

Catalog Number 114745L

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported four minutes after starting treatment with a revaclear 300 dialyzer, the patient experienced a blood pressure drop, became pulseless and unresponsive.The medical intervention consisted of 2.5l saline after which the patient responded.Treatment was terminated.It was reported this was the first use with the revaclear dialyzer.Pre-treatment blood pressure was 122/59 mmhg and pulse 71 bpm.At the time of this report, the patient was recovered.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 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• MDR Report Key: 8514803
• MDR Text Key: 141949210
• Report Number: 3006552611-2019-00015
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123055
• UDI-Public: (01)07332414123055
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2021
• Device Catalogue Number: 114745L
• Device Lot Number: C618317902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR