MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8671

Device Problem Free or Unrestricted Flow (2945)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during patient infusion of levophed, phenylephrine and amiodarone with 3 units of clearlink system extension sets, an inadvertent bolus from the extension filter was observed.This resulted in the patient experiencing hypertension reported as ¿caused the blood pressure to skyrocket¿.According to the reporter, the filter emptied out on its own.No connection issues were noted and the lines were setup properly.After the "filters were removed, the patient's blood pressure "evened out".No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a companion sample was received for evaluation.Visual inspection with the naked eye of the companion sample did not identify any abnormalities that could have contributed to the reported condition.Functional testing including clear passage and under water pressure testing were performed.The companion samples were determined to meet functional performance specification requirements.The reported condition was not verified.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 SOLUTION ADMINISTRATION SETS
• 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: 14339574
• MDR Text Key: 291239214
• Report Number: 1416980-2022-02326
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412046334
• UDI-Public: (01)00085412046334
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153158
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8671
• Device Lot Number: R20H06113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2020
• 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: AMIODARONE; LEVOPHED; PHENYLEPHRINE
• Patient Outcome(s): Other