MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8541

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Lot #: the lot was either suspect lot r21a28061 or r21a19128.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a side port of a clearlink system continu-flo solution set had a faulty seal leading to a chemotherapy leak.This was identified during patient use.The port was not accessed by pharmacy or nursing.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The suspected lot # r21a28061 was manufactured on january 29, 2021.The suspected lot # r21a19128 was manufactured on january 20, 2021.A batch review was conducted for each of the reported suspect lots and there were no deviations found related to this reported condition during the manufacture of these lots.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11708219
• MDR Text Key: 248595518
• Report Number: 1416980-2021-02335
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8541
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARBOPLATIN