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

Catalog Number ASKU

Device Problem Fluid 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.

• 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

• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• 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 Treatment Data

Date Received: 05/09/2022 Patient Sequence Number: 1

Treatment

AK 96