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

Lot Number ASKU

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

It was reported that a leak was observed while disinfecting a u9000 ultrafilter.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Initial reporter address: (b)(6).Initial reporter phone no.(b)(6).The device was evaluated onsite by the baxter technician and confirmed that the elbow connector of evacuation valve (evva) was disconnected and the ultrafilter was leaking.To resolve the issue, the qualified technician put the connection back in position firmly and replaced the ultrafilter.Based on past investigations, the most likely failure is a crack in the housing nearby the welding zone.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 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: 15675285
• MDR Text Key: 305219236
• Report Number: 9611369-2022-00203
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: No
• 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 96 MACHINE