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

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.

• Brand Name: ULTRAFILTER U9000
• Type of Device: DIALYZER, 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 Key: 12475245
• MDR Text Key: 271502087
• Report Number: 9611369-2021-00235
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2021

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
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AK 98