• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE - OPELIKA REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVACLEAR 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - OPELIKA
opelika AL
MDR Report Key7814333
MDR Text Key118262724
Report Number3006552611-2018-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K130039
Number of Events Reported1
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 Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114746L
Device Lot NumberC418211501
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2018
Distributor Facility Aware Date07/30/2018
Event Location Hospital
Date Report to Manufacturer08/24/2018
Date Manufacturer Received08/31/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/24/2018 Patient Sequence Number: 1
Treatment
CARTRIDGE; HOSPIRA 0.9% NACI SALINE BAG; PHOENIX / INNOVA MACHINE; REXEED 25S (NON-BAXTER PRODUCT)
-
-