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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION BAXTER CLEARLINK NON-DEHP EXTENSION SET 16" WITH 0.2 MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number ITEM #2H8671
Device Problem Inaccurate Flow Rate (1249)
Patient Problems Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)
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 second case involved the drug epoprostenol used for pulmonary hypertension.A pt was continued on her home dose / rate of epoprostenol when admitted to the hosp.Despite continuing her home regimen, she soon had increased respiratory effort and rate.This lead to rapid response being called, and transfer to the icu.Two other events of desaturation occurred three days after the initial increased respiratory rate.The epoprostenol concentration was lowered due to concerns that the line was backing up.Only then was the pt stabilized and transferred out of the icu and eventually discharged.Ref mw5090871, mw5090868.Fda safety report id# (b)(4).
 
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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 Key9279567
MDR Text Key165394420
Report NumberMW5090870
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
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 Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberITEM #2H8671
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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