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

Catalog Number 2H8519

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 03/26/2022

Event Type  malfunction  

Event Description

It was reported that a clearlink system non-dehp continu-flo solution set leaked.The event was further described as; after medicine administration, air alarm was triggered.Pump was opened and solution leakage was evidenced.Ruptured line was evidenced.This was identified during infusion pump washing with saline solution.During medicine administration no alarm was triggered, therefore, the medicine was completely administered.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Initial reporter phone no.(b)(6).Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph using the naked eye observed a hole in the tubing.The reported condition was verified.Due to the nature of the returned sample, no additional testing could be performed.The cause of the condition could not be determined.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 CONTINU-FLO SOLUTION SET
• 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 ; 2242702068
• MDR Report Key: 14197092
• MDR Text Key: 290045120
• Report Number: 1416980-2022-02035
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048451
• UDI-Public: (01)00085412048451
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8519
• Device Lot Number: R21G07047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2021
• 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
• Treatment: UNSPECIFIED BAXTER PUMP
• Patient Age: 6 YR
• Patient Sex: Male