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

Model Number	7300
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: no product was received for analysis.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.The service history review had no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the cadd-solis vip pump had consistently produced downstream occlusion alarms during the priming step (prior to patient connection).All clamps had been confirmed open on the tubing.This issue had occurred with multiple tubing sets from the same lot.The reporter noted that the patient had been using the same pump and tubing model for several months prior to the onset of this issue.The patient had occasionally been able to initiate infusion successfully.The downstream occlusion alarm had recurred intermittently throughout the infusion process which led to the discontinuation of therapy.The infusion provided was sodium chloride 0.9% injection solution 250 ml/hr.Up to 4 times per day.The replacement of the pump was sent to the patient, and it resolved the issue for the time being.There was a delay in therapy.There was no patient harm reported.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22297432
• Report Number: 3012307300-2025-07387
• Device Sequence Number: 8738270
• Product Code: FPA
• UDI-Device Identifier: 15019517191776
• UDI-Public: (01)15019517191776(17)300401(10)6108504
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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 Model Number: 7300
• Device Catalogue Number: 21-7364-24
• Device Lot Number: 6108504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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 Sex: Unknown