MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HD CARTRIDGE LINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION

Catalog Number	101025
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an external fluid leak was observed originating from the venous chamber of a gambro cartridge set during prime.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h3, h4, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation along with eight (8) retained samples.During visual inspection of the provided photographic sample a segment of the cartridge installed to a hemodialysis machine, in the upper part of the port of pump tube the presence of liquid/solution was observed in the arterial chamber.The reported condition was verified.However, due to the nature of the provided samples, no further testing could be performed.Therefore, the cause of the condition could not be determined.Based on the leakage point a possible root cause could be associated to a short shoot located at cartridge plate.This condition could be generated at the upper sides of the cartridge during the molding process of the cartridge plate, during the material injection, the mold cavity is filled, and the upper side is the last side that is filled due injection point is located at the bottom of the piece.Conditions that lack or have blocked vents in the mold could contribute to this defect.For the retained samples, the visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sets underwent functional testing including leak testing by injecting air pressure of 27.17 psi for ten minutes under water and no leaks were observed in any of the sets.The reported condition was not verified.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: HD CARTRIDGE LINES
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TIJUANA BAJA; blvd pacifico 10014; parque industrial pacifico; tijuana baja california CP 22 643; MX CP 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18030435
• Report Number: 8030638-2023-00028
• Device Sequence Number: 20321913
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070414
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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: 04/15/2025
• Device Catalogue Number: 101025
• Device Lot Number: MA0122137647
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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
• Patient Sex: Unknown