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 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.A potential cause of the condition could have been a crack in the housing nearby the welding zone.A nonconformance has been established to further investigate.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during priming 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: 14159863
• MDR Text Key: 290463770
• Report Number: 9611369-2022-00064
• 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
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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
• Date Manufacturer Received: 03/29/2022
• 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 98