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 Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that 15 minutes after starting treatment with a cartridge line, an external blood leak between the arterial patient line and the arterial injection port was observed.It was further reported an alarm was generated.According to the reporter it was ¿a clean cut¿ and ¿the tubing just cut off and the patient started bleeding out".The blood loss was 700-1000 ml.No clinical symptoms were reported; however, ¿extra fluid¿ was administered to the patient prior to leaving.No additional information is available.
Additional Manufacturer Narrative
Additional information added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.Visual inspection with the naked eye showed a disconnection at the transport tube and the arterial red access point.There was no solvent observed at the tip of the transport tube (where it is assembled with the arterial access point), and the arterial access point had no solvent at its port.The reported condition was verified.Seven (7) photographs of the sample were provided for evaluation and showed the connection of the transport tube detached from the arterial red access point.Eight (8) retain samples of the same involved lot number (ma0122333011) were received for evaluation.The samples were visually inspected with the naked eye and leak testing was performed.The retained samples were found within the specifications.The cause of the condition was determined to be a manufacturing issue.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: 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: 17333452
• Report Number: 8030638-2023-00015
• Device Sequence Number: 6573746
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Catalogue Number: 101025
• Device Lot Number: MA0122333011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown