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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Fluid Leak (1250); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2017
Event Type  malfunction  
Event Description
Patient's son noticed some leaking around the patient's subcutaneous infusion site when changing the dressings. The son's patient reported that the cannula from the cleo infusion set was stuck in the patient's skin. The cannula was approximately 3/8 inches long. The subcutaneous site was removed and placed elsewhere. The new site does not have any drainage or leakage. The infusion was not interrupted and the patient remains infusing at 13. 3 ng/kg/min without issue. No further information was provided. The patient does not have the lot # as the cleo was a supply that was used in the hospital when therapy was initiated, she only has the needle portion that was broken off still in her possession, she did state that it was ok for the mfr to reach out to her for more information. Dose or amount: 13. 3 ng/kg/min, frequency: continuous, route: subcutaneous. Dates of use: from (b)(6) 2017 to ongoing. Diagnosis or reason for use: primary pulmonary hypertension.
 
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Brand NameCLEO INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
MDR Report Key6530009
MDR Text Key74145759
Report NumberMW5069437
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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