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

Catalog Number 101025

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2023

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 319370374
• Report Number: 8030638-2023-00015
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: MA0122333011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention