MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ULTRAFILTER U9000; SUBSYSTEM, WATER PURIFICATION

Catalog Number	112062
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external fluid leak was observed from two (2) u9000 ultrafilters during hemodialysis therapy with an ak95 machine.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction: d4: lot number additional information: h6, h11 h11: the actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photos did not identify any abnormalities that could have contributed to the reported condition.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was not determined as no further or actual sample testing could be performed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6, h11.Six (6) companion samples were received for evaluation.During visual inspection, no conspicuous features related to the reported failure were identified.The process data was reviewed based on the companion sample barcodes, and no issues were noted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ULTRAFILTER U9000
• Common Device Name: SUBSYSTEM, WATER PURIFICATION
• 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 60073 ; 2242702068
• MDR Report Key: 21096025
• Report Number: 9611369-2024-00240
• Device Sequence Number: 15729771
• Product Code: FIP
• UDI-Device Identifier: 07332414102500
• UDI-Public: 07332414102500
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K201809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 112062
• Device Lot Number: 3-1901-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 03/04/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/05/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AK95 MACHINE
• Patient Sex: Unknown