MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7094-24
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.
Event or Problem Description
It was reported, that the patient had stated, that frequent warnings had been received on their cadd pumps, including ¿upstream occlusion,¿ ¿downstream occlusion¿ and ¿cassette not attached¿.There was patient involvement.And no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during functional testing when the reported alarm was duplicated.However, the investigation could not identify a root cause for the observed issue.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Complaint information will continue to be monitored.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20865022
• Report Number: 3012307300-2024-14525
• Device Sequence Number: 12971387
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: (01)10610586025266(17)290408(10)6005509
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K933390
• 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,Followup
• Report Date (Section B): 05/12/2025

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: 21-7094-24
• Device Lot Number: 6005509
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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