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

Catalog Number	21-7391-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the pump was beeping and the medication was empty and needed a new bag.Per reporter, it was noticed that the tubing was leaking at the bottom of the base, from the tubing in the cassette.Per reporter, there was no concern with the pump itself and no injury to the patient.
Additional Manufacturer Narrative
D9.Date returned to mfg: 13-jan-2025.H6.Investigation codes: updated.One sample was received.As received, there were no damages or anomalies observed.In order to replicate clinical use, the admin set line was primed with the provided syringe and attached to a hanging saline bag.The admin set was then installed on a cadd-solis pump and 10ml of priming was performed.A leak was observed at the outlet tube of the cassette.No cassette errors, occlusion alarms, or air in line alarms were generated.The complaint of leakage can be confirmed.The probable cause is due to inconsistent solvent application at the junction.A device history record could not be completed as no lot number was received.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; tijuana MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21128583
• Report Number: 3012307300-2025-00572
• Device Sequence Number: 7583531
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: (01)10610586027512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 21-7391-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD PUMP.; DILAUDID.
• Patient Age: 58 YR
• Patient Sex: Unknown