MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK NITROGLYCERIN SET WITH DUO-VENT SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8851
Medical Device Problem Codes	Backflow (1064); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood backed up into the tubing of an unspecified quantity (at least two) of clearlink system nitroglycerin sets.The pump registered that there was air in the tubing.This occurred during patient infusion.The tubing was disconnected from the patient to trouble shoot the problem, but the air would again back up into the medication bottle.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the actual device was not available; however, four companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.Functional testing included pressure testing and clear passage under water testing, and no issues were noted.Priming was performed with no issues noted.A simulated therapy was also performed, and there were no issues noted.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: CLEARLINK NITROGLYCERIN SET WITH DUO-VENT SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18784371
• Report Number: 1416980-2024-00759
• Device Sequence Number: 12720968
• Product Code: FPA
• UDI-Device Identifier: 00085412046365
• UDI-Public: (01)00085412046365
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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 Catalogue Number: 2C8851
• Device Lot Number: R23H08093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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
• Patient Sex: Unknown