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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 Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone no. : (b)(6). 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 a blood leak was observed in the "connections going to the patient (in the red port)" on one (1) unit of an oxiris set due to "connection did not seal". The event occurred shortly after starting treatment. 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 
2242702068
MDR Report Key12453647
MDR Text Key271126627
Report Number8010182-2021-00269
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414102234
UDI-Public(01)07332414102234
Combination Product (y/n)Y
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number112016
Device Lot Number21A0501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2021
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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