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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OXIRIS S DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION OXIRIS S DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955503
Device Problem Air/Gas in Device (4062)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/21/2022
Event Type  Injury  
Event Description
It was reported that during continuous renal replacement therapy (crrt) with three oxiris sets and a prismax machine, air was reported to have entered the entire oxiris set. After each event, treatment was discontinued and the set "had to be primed again. " the air detection alarm was generated, and no defects were observed on the sets. The extracorporeal blood was not returned to the patient which resulted in a 600 ml blood loss. The patient received a blood transfusion and albumin. 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. Oxiris set has been temporarily approved for use in the us under emergency use authorization eua(b)(4) with a specific indication to treat patients with covid-19 infection.
 
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Brand NameOXIRIS S
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 Key13892155
MDR Text Key288670808
Report Number8010182-2022-00076
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955503
Device Lot Number21H2802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
Treatment
NI.
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