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

Catalog Number 2C8537

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported during patient infusion of vasopressin with a clearlink continu-flo solution set, the patient's blood pressure began to drop precipitously.It was further reported the medication was flowing into the patient¿s bed where the tubing had become disconnected, at the y site.The cause of the disconnection was not reported.A new bag of vasopressin was set up with a new set and therapy was restarted.The patient outcome was reported as the patient¿s blood pressure returned.No additional information is available.

Manufacturer Narrative

Manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.Visual inspection with the naked eye identified the tubing was separated from the third y- site in the "upstream part".The reported condition was verified.A lack of solvent could affect the bonding performance generating separation between tubing and y-site.The cause of the reported condition was a manufacturing issue.A nonconformance has been opened to address this issue.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 CORPORATION; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15321854
• MDR Text Key: 298903617
• Report Number: 1416980-2022-04517
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203609
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8537
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: VASOPRESSIN
• Patient Outcome(s): Required Intervention