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 Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
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 a cadd administration set (69", m/m, fs, totm, 12/bx, item #21-7359-24) was in use when the pump alarmed for an upstream occlusion multiple times.Although the infusion would briefly continue, the alarm would reoccur several seconds later.This was the second occurrence for the same patient, both incidents happening on disconnect day.At the time of the event, 3.4 ml of volume remained (equivalent to 1 hour and 33 minutes of infusion) the tubing is available for return along with the pump.The event occurred while the device was in use with a patient.
Additional Manufacturer Narrative
One used sample attached to an equashield and a medication bag was received for the evaluation.As received no damage or anomalies were observed.In attempts to replicate clinical use the medication bag was filled with 30 ml of sterile water and the set was inserted into a cad solis pump.They attempted to prime the set with 10 ml; however, a downstream occlusion alarm was returned instead.The equashield was removed and the priming was reinitiated.No further alarms or difficulties priming were observed.A second 10 ml priming was attempted.No alarms were observed.The customers¿ complaint of the upstream occlusion alarm could not be replicated or confirmed.A device history review found no discrepancies or anomalies relevant to the complaint.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22196638
• Report Number: 3012307300-2025-06952
• Device Sequence Number: 15780618
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: (01)10610586027406(17)290807(10)6037654
• 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,Followup
• Report Date (Section B): 07/21/2025

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: Lay User/Patient
• Device Catalogue Number: 21-7359-24
• Device Lot Number: 6037654
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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