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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPXIRIS 150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION SEPXIRIS 150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955617
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
Prismaflex sepxiris set 150 (jp) is similar to prismaflex st150 set, prismaflex st150 set ckt, and prismaflex st150 set c. Prismaflex st150 set, prismaflex st150 set ckt, and prismaflex st150 set c have been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during priming, an external fluid leak was observed from a crack on the one-way valve of the heparin line from a sepxiris 150. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
Additional information added. 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 NameSEPXIRIS 150
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11327826
MDR Text Key245090988
Report Number8010182-2021-00049
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2021
Device Catalogue Number955617
Device Lot Number19L1005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
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

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