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

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	05/02/2023
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 was fluid leak from the back of the venous chamber of a gambro catridge.The leak was further described as, ¿when placing the cassette and priming it, a very fine and continuous liquid jet was observed coming out from the back of the venous chamber, around the circle formed where the machine's sensor is inserted¿.This issue was observed during priming prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: e1, h3, h4, h6 and h10.(b)(6).H10: the actual device was discarded; however, a photograph of the sample was provided for evaluation and eighteen (18) retained samples were evaluated.During visual inspection of the provided photographic samples, the pictures were not clear enough to observe any deviation in the bloodline that could contribute to the reported leakage.The reported condition was not verified.For the retained samples, the visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sets underwent leak testing by injecting air pressure of 26 psi for ten minutes under water and no leaks were observed for all 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 VALVE
• 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: 17020252
• Report Number: 8030638-2023-00012
• Device Sequence Number: 20677159
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: MA0122123602
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2022
• 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