MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	UNKNOWN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Rash (2033); Weight Changes (2607)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced multiple adverse events, including headache, fatigue, loss of appetite, infusion site pain, infusion site rash, adhesive tape allergy, weight loss, catheter site-related reaction, device dislodgement, wireless communication issues with the device, and overall dissatisfaction with the device.The patient began therapy with remodulin (treprostinil sodium, concentration 10.0 mg/ml) delivered via the remunity [self-filled] pump.The reported dose was 0.03125 g/kg, administered continuously via the subcutaneous (sq) route using a self-filled cassette containing 1.9 ml at a rate of 19 l per hour.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The root cause was unable to be established.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD CLEO INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22556266
• Report Number: 3012307300-2025-08634
• Device Sequence Number: 9894554
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: (01)30610586028414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: "K042172 "
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 99 KG