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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 115539
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number: (b)(6).Facility name: (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an external saline leak and a damage were observed from the effluent port of a sepxiris 150 set during priming.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information added to h10.Upon further review, it was determined that this device is not same as or similar to a device that is manufactured or distributed in the us.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
SEPXIRIS 150
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11832541
MDR Text Key250894198
Report Number8010182-2021-00164
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414119720
UDI-Public(01)07332414119720(10)
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 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/01/2022
Device Catalogue Number115539
Device Lot Number20I1402
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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