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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION OXIRIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 112016
Device Problems Material Perforation (2205); Free or Unrestricted Flow (2945)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
Oxiris has been temporarily approved for use in the us under emergency use authorization (b)(4) with a specific indication to treat patients with covid-19 infection. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an overflow occurred on one unit of oxiris from a probable hole in the extension set. The process step was not specified. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameOXIRIS
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 Key11109103
MDR Text Key225034763
Report Number8010182-2020-00330
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue Number112016
Device Lot Number20F0503
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 Received01/25/2021
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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