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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION REVACLEAR 300 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114745L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tachycardia (2095); Reaction (2414)
Event Date 11/25/2020
Event Type  Injury  
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.
 
Event Description
It was reported that after two and half hours of therapy using a revaclear 300, the patient experienced generalized pruritus without hemodynamic changes. At the time of the event, the oxygen saturation was 100%, fio2: 21% and heart rate of 59 bpm. Ten minutes later the patient presented with sinus tachycardia 90 bpm and ¿anxious allergy¿. Treatment was stopped and administration of hydrocortisone 200 mg intravenously was provided. The patient was observed for 30 minutes. It was reported the patient was ¿feeling well¿ and left without any symptoms. No additional information is available.
 
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Brand NameREVACLEAR 300
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 60073
2242702068
MDR Report Key11048106
MDR Text Key222830975
Report Number3006552611-2020-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCO
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114745L
Device Lot NumberC620306802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2020
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: 12/21/2020 Patient Sequence Number: 1
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