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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - OPELIKA REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 110634
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Respiratory Distress (2045)
Event Type  Injury  
Manufacturer Narrative
The initial onset was reported as on (b)(6) 2018 and then on (b)(6) 2018 and lastly the (b)(6) 2018. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient undergoing treatment with a revaclear max dialyzer experienced hypersensitivity reactions. On the date of onset of reactions, no medical intervention was reported for this occurrence. Two days later and 15 minutes into treatment with the same dialyzer, the patient experienced a ¿first anaphylactic reaction¿ and was later hospitalized that same day. The patient was treated with and an epi-pen (epinephrine injection). Two days later, the patient while undergoing treatment with the same device, experienced a "severe anaphylactic reaction". The patient's symptoms at time of reaction ranged from ¿hives, closing of throat, difficult breathing, weaving¿. An epi-pen was administered and the symptoms decreased. At the time of this report, the patient was still hospitalized. No additional information is available.
 
Manufacturer Narrative
The device has been received, the sample was analyzed for pvp/nmp content per protocol and the results were within expectation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameREVACLEAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - OPELIKA
opelika AL
MDR Report Key7907912
MDR Text Key121707822
Report Number3006552611-2018-00014
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K060195
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/27/2020
Device Catalogue Number110634
Device Lot NumberC418205501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/25/2018 Patient Sequence Number: 1
Treatment
REVACLEAR DIALYZER
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