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 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was not received for evaluation; however, the device was evaluated on site by a qualified technician.Upon evaluation a leakage was identified.To resolve the issue, the qualified technician replaced the u9000.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause is a crack in the housing nearby the welding zone.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during disinfection with the u9000 filter, an external fluid leakage 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14754115
• MDR Text Key: 303163368
• Report Number: 9616026-2022-00059
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 05/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AK 96 MACHINE