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

Catalog Number	21-7359-24
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump was alarming downstream occlusion repetitively and patient experienced a chemo spill.Needle removed from port and patient discharged.Patient came in for port site assessment, port site was red and irritated no known harm for patient.Patient did not receive intended dose.Drug being infused was fluorouracil.Continuous infusion rate was 3 ml/hr.Reservoir volume: original volume to be infused was 138 ml.Given was 108 ml.Length of infusion: intended 46 hours.Lock level was unknown.A closed system drug-transfer device was used to fill cassette.The pump was used to prime the extension tubing.There was patient involvement, and no patient harm/adverse event reported.Possible lot numbers 6037654, 6026751, 6005535.
Additional Manufacturer Narrative
No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: CADD ADMINISTRATION SET
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21358999
• Report Number: 3012307300-2025-01748
• Device Sequence Number: 8481659
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: (01)10610586027406
• 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): 02/11/2025

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: 21-7359-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/11/2025
• 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 Sex: Unknown