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

Catalog Number ASKU

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was evaluated on site by a qualified technician.An evaluation of the equipment confirmed an alarm in the blackbox.Upon visual inspection, the qualified technician found a leakage at the u9000.To resolve the issue, the qualified technician replaced the u9000 and then the machine was running normally.Based on past investigations, the most likely failure is a crack in the housing nearby the welding zone.This is design related.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during self-check with a u9000 filter, a water leak was observed.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6 and h10 h10: the device was inspected on site by a qualified technician.The u9000 was observed to have a water leak and it was replaced.The most likely cause is due to a crack in the housing near the welding zone.This is a design related.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ULTRAFILTER HECHINGEN
• Type of Device: 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 ; 2242702068
• MDR Report Key: 14337050
• MDR Text Key: 291215219
• Report Number: 9611369-2022-00072
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/03/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AK 96