MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114746L

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

The patient is (b)(6) years of age.Should addition relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that approximately 15-30 minutes during treatment with a revaclear dialyzer, the dialysis machine generated several "air in blood" alarms.Eventually the alarms cleared but no air or bubbles could be observed within the extra-corporeal circuit.As result of the alarms, the patient experienced shortness of breath and chest pain.Patient was placed in minimum ultrafiltration rate and in a trendelenburg position and received saline due to hypotension.Reportedly the symptoms dissipated.No further information provided.

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 actual device was not available for evaluation since it was discarded at customer site.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 - OPELIKA; opelika AL
• MDR Report Key: 7814333
• MDR Text Key: 118262724
• Report Number: 3006552611-2018-00008
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2018,09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114746L
• Device Lot Number: C418211501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2018
• Distributor Facility Aware Date: 07/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2018
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE; HOSPIRA 0.9% NACI SALINE BAG; PHOENIX / INNOVA MACHINE; REXEED 25S (NON-BAXTER PRODUCT)
• Patient Outcome(s): Other