MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LINE ACCESSORIES; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	107650
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there were three (3) separate incidents of external fluid leaks from 9 liter effluent bags during use on three (3) patients.The leakage occurred on both sides of the bag drain valve.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, a drawing of a 9 liter effluent bag was provided for evaluation, indicating the leak occurred along the bottom weld of the effluent bag.A companion sample was received and visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including a push-pull and underwater leak test.No disconnects were noted and no leaks were identified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LINE ACCESSORIES
• Common Device Name: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa NI ; MT NI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19093075
• Report Number: 1416980-2024-01660
• Device Sequence Number: 7651236
• Product Code: MON
• UDI-Device Identifier: 07332414075828
• UDI-Public: (01)07332414075828
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 107650
• Device Lot Number: 23A06V147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX MACHINE
• Patient Sex: Unknown