MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER CLEARLINK NON-DEHP EXTENSION SET 16" WITH 0.2 MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number ITEM #2H8671

Device Problem Improper Flow or Infusion (2954)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

There have been three different cases involving pts receiving medication infusions at an impaired / incorrect rate with the use of the baxter brand filter.This possible device error has potentially affected pts' clinical course in the hosp.The third case also involved epoprostenol.This pt was admitted for shortness of breath and she was, similar to the second case, continued on her home dose and regimen.Despite this, the pt desaturated requiring rapid response and transfer to the icu.The pt experienced add'l episodes that required rapid response and add'l transfers in and out of the icu.The pulmonary hypertension rn examined the pt and examined the pt and noticed that the infusion was not flowing forward at the pt's insertion site; therefore the epoprostenol concentration was lower.It was only then that the pt's status stabilized and she was able to be transferred out of the icu.Of note, this pt was also admitted 6 months prior to this event with the same chief complaint.She was continued on her home regimen of the epoprostenol at that time and no issues were reported.The only difference between the two hospitalizations is that the institutions started using the baxter filters for infusions.The three cases involved different medications, pumps, and staff, but all three of these cases used the baxter filter, so there's a concern that the filter is causing infusion flow problems.Ref mw5090870, mw5090871.

• Brand Name: BAXTER CLEARLINK NON-DEHP EXTENSION SET 16" WITH 0.2 MICRON FILTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 9279528
• MDR Text Key: 165463404
• Report Number: MW5090868
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ITEM #2H8671
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention