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

Model Number	7300
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 - lot #: possible lots 6061452, 6071181.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 device under delivered.Per reporter the device alarmed "infusion complete or empty", however, the patient did not receive the entire medication/bag.The pump indicated that infusion was complete but there was definitely at least 100 ml left in bag.A continuous infusion rate of 6 ml/hour had been programmed, with a total reservoir volume of 275 ml and given 275 ml but there was still at least 100 ml in the bag.The air detector and upstream sensor had been turned off.The length of infusion had been set to 46 hours, and the lock level had been set to ll2.A closed system drug transfer device (cstd) was used to fill cassette.There was patient involvement, but no patient harm reported.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: PUMP, INFUSION
• 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: 22413258
• Report Number: 3012307300-2025-07953
• Device Sequence Number: 18557927
• Product Code: FRN
• UDI-Device Identifier: 10610586029646
• UDI-Public: (01)10610586029646
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: 21-7322-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/07/2025
• 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 Sex: Unknown