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

Catalog Number 2C8519

Device Problem No Flow (2991)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/14/2021

Event Type  Injury  

Event Description

It was reported that during a patient infusion with a clearlink continu-flo solution set, the nurse found the tubing kinked which resulted in an interruption of the medication.Subsequently, the patient experienced ¿profound hypotension¿.After the tubing was changed, the patient was receiving a vasopressor infusion at a rate of 16.9 ml.According to the reporter, ¿immediately nurse needed to escalate dose¿.Dose escalation continued over the next 18 minutes until the nurse checked the tubing and found it kinked.The medication was titrated with a maximum rate of 75cc/hr over 18 minutes.The medical intervention for the event was reported as medication escalation.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Device manufacturer address (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.A potential cause of the condition could have been related to 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 - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14987920
• MDR Text Key: 295707027
• Report Number: 1416980-2022-03596
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8519
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• 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: SPECTRUM IQ PUMP
• Patient Outcome(s): Required Intervention