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

Catalog Number 2H8671

Device Problem Infusion or Flow Problem (2964)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

The customer reported this event to the fda through medwatch mw5090868.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during a patient home infusion with a clearlink solution set, the patient experienced shortness of breath.The patient was admitted to the hospital for the event.Treatment for the event was not reported; however, the patient was continued on the home dose and regimen.It was reported the patient desaturated requiring rapid response and transfer to the intensive care unit (icu).The patient experienced additional episodes that required rapid response and additional transfers in and out of the icu.It was reported the nurse observed that the infusion was not flowing forward at the patient's insertion site.It was noted the infused medication concentration was lower.It was reported the patient stabilized and was able to be transferred out of the icu.It was reported the patient was continued on the home regimen of the medication and no issues were reported.No additional information is available.

Manufacturer Narrative

Additional information: the device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.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 60073 ; 2242702068
• MDR Report Key: 9503605
• MDR Text Key: 172224658
• Report Number: 1416980-2019-07056
• Device Sequence Number: 1
• Product Code: FPA
• 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: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8671
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization