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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114748
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported during treatment with a revaclear 300 dialyzer an external dialysate leak at an unspecified connector was observed.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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.
 
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Brand Name
REVACLEAR 300
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
MDR Report Key8165186
MDR Text Key131497864
Report Number9611369-2018-00144
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414114947
UDI-Public(01)07332414114947
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,foreig
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Catalogue Number114748
Device Lot Number8-9619-H-01
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTISET BLOOD TUBING SYSTEM
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