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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114746L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943)
Event Date 11/22/2021
Event Type  Injury  
Event Description
It was reported that sixteen (16) minutes into treatment with a revaclear 400, the patient experienced difficulty breathing, pruritus, restlessness and low blood pressure. Treatment was discontinued without returning the extracorporeal blood to the patient (no blood pressure values were reported). The patient received benadryl and solumedrol for the events. At the time of this report, the patient outcome was not reported. No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameREVACLEAR 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - OPELIKA
1101 jeter ave
opelika AL 36801
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13061052
MDR Text Key282633950
Report Number3006552611-2021-00014
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114746L
Device Lot NumberC621400807
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
Treatment
NORMAL SALINE; TORAY
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