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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 Fluid Leak (1250)
Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359)
Event Date 12/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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; however, a photograph of the sample was provided for evaluation. The picture was inspected and blood was visible on one end of the device, underneath the header cap area. The blood outside of the fiber bundle was consistent with a leak event. The reported condition was verified. The cause could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that while using a revaclear 300, and upon returning the extracorporeal blood at the end of treatment, an internal blood leak was identified at the filter through the arterial side. A blood leak alarm was noticed. The extracorporeal circuit was immediately closed, the restitution was stopped and the patient was disconnected. After disconnection, the patient reported "feeling bad", and they also experienced symptoms of hypotension. A blood loss greater than 150 ml was reported. The patient was administered 400 ml of normal saline intravenously and they felt better 30 minutes later. It was reported the patient left the unit in "good conditions". 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 Key11194723
MDR Text Key227562123
Report Number3006552611-2021-00003
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 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114745L
Device Lot NumberC620306903
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 Received12/23/2020
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 Unkown

Patient Treatment Data
Date Received: 01/19/2021 Patient Sequence Number: 1
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