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 Hyperglycemia (1905)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported during patient infusion with a clearlink continu-flo solution set, the male luer of the set disconnected from the central line of the patient which resulted in a leak.It was further reported ¿diachylon" on the end of the tubing was observed.The patient was receiving fentanyl (150 mcg/hr.), insulin ("iv" 20ml/hr.) and propofol (unreported dose) at the time of the event.Subsequently, the patient experienced agitation, hyperglycemia and was less sedated due to the event.The tubing was changed, and the medication was restarted.After the insulin was restarted the patient glucose was 21.1 and 23.3 (units not reported).The cause of the disconnection was unknown.The patient returned to ¿normal glycemia¿ and the agitation was resolved.No additional information is available.

Manufacturer Narrative

Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; therefore, a device analysis could not be completed.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; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13994973
• MDR Text Key: 288486044
• Report Number: 1416980-2022-01541
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048970
• UDI-Public: (01)00085412048970
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K203609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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: R21K30055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Date Device Manufactured: 12/01/2021
• 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: FENTANYL; INSULIN; PROPOFOL; UNKNOWN BAXTER PUMP
• Patient Outcome(s): Other