MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK PACLITAXEL SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2R8858

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink, paclitaxel set leaked from "one of the splices" (pump segment).This was identified after priming with saline.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was returned for evaluation.A visual inspection identified that there was an incorrect assembly at the tubing and the bushing.Functional tests which included pressure and clear passage under water tests were performed which revealed a leak between the assembly of the tubing into the bushing.The reported condition was verified.The cause of the condition was determined to be a manual assembly related issue during the manufacturing process.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 PACLITAXEL SETS
• Type of Device: 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: 18405381
• MDR Text Key: 331505542
• Report Number: 1416980-2023-06785
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412565774
• UDI-Public: (01)00085412565774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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
• Device Operator: Other
• Device Catalogue Number: 2R8858
• Device Lot Number: R23D24024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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