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

Catalog Number 114604

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported that before use with a u9000 ultrafilter, an external fluid leakage from cap was observed.It was further reported the product had been used for 46 days and had been disinfected for 48 times.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was not available for evaluation; however, three photographs were provided for evaluation.Visual inspection of the first picture shows the head area of the ultrafilter.The product is out of the packaging and wet.The second picture shows the product with part of the product label (lot number and barcode are visible).Photo three shows the monitor screen.The reported condition was verified.The most likely cause of the condition could be due to a crack in the housing nearby the welding zone.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 14578037
• MDR Text Key: 293263495
• Report Number: 9611369-2022-00093
• Device Sequence Number: 1
• Product Code: FIP
• UDI-Device Identifier: 07332414114046
• UDI-Public: (01)07332414114046
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 114604
• Device Lot Number: 1-1802-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2021
• 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