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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ULTRAFILTER U9000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION ULTRAFILTER U9000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number ASKU
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number: (b)(6). The device was inspected on site by a technician and a leak was observed at the top cover of the u9000 due to a crack. Based on past investigations, the most likely failure is a crack in the housing nearby the welding zone. The reported condition was verified. The cause of the crack is material related. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a leak was observed on an u9000 during treatment. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameULTRAFILTER U9000
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
holger - crafoord - strasse 26
hechingen D-723 79
GM D-72379
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12475245
MDR Text Key271502087
Report Number9611369-2021-00235
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCH
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
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
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 Unkown

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
Treatment
AK 98
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