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

Catalog Number ASKU

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device was discarded, and the lot number is unknown; 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 the header and housing material.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 leakage and outer shell damage (unspecified) was observed.The filter was replaced and no issues were noted.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to h6 and h10 h10: phone support was provided by the qualified technician.The outer shell of the u9000 was observed to be damaged and had a water leak.The reporter was instructed over the phone in replacing the u9000 and the machine was ran normally.Based on past investigations, the most likely cause was due to a crack in the housing near the welding zone.The cause was 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: 14408420
• MDR Text Key: 291738753
• Report Number: 9611369-2022-00084
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/03/2022

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: 04/22/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: AK 98