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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPXIRIS 100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION SEPXIRIS 100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115538
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an external fluid leak was observed from a crack on the extension of a sepxiris100. This event occurred during priming. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation and was received without the damaged extension line. A leak test was performed on the filter and no leak was observed. No issues were observed with the dialysate port of the filter. The reported condition was not verified. The cause of the condition could not be confirmed. 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 NameSEPXIRIS 100
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10924597
Report Number8010182-2020-00267
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414119713
UDI-Public(01)07332414119713
Combination Product (y/n)Y
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2022
Device Catalogue Number115538
Device Lot Number20C0205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
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