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

Catalog Number	21-7044-24
Medical Device Problem Codes	Failure to Infuse (2340); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when making changes on the pump, the pump alarmed for occlusion.It was tried to prime again; however, it still was not working and then they had to use another extension.The patient had 2 extensions that did not work.The event did not occur during patient use.
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.
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.
Additional Manufacturer Narrative
D9: date returned to mfg.: 11/18/2024.Received 2 devices, the complaint of extension set not working can be confirmed.The probable cause is due to filter saturation leading to partial/complete flow occlusion.As received no damage or anomalies were observed.In attempts to replicate clinical use each extension set was connected to a 100ml cassette reservoir and inserted into a cad solis pump (serial #(b)(6)) and 10 ml were primed.A downstream occlusion alarm was returned with each set.No flow was observed to make it past the filter of either set.After cutting the outgoing tubing of each filter, no occlusion was observed at the filter.The priming was repeated a temporary downstream occlusion alarm was observed.The filter was cut out and the priming test was repeated.No errors, occlusion alarms, or air in line alarms were generated and no restrictions in flow were noted on either set.The filters were found to fail flow specifications.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN ; MX
• Manufacturer Contact: reed covert ; .6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20727349
• Report Number: 3012307300-2024-13590
• Device Sequence Number: 18366161
• Product Code: FPA
• UDI-Device Identifier: 15019517184204
• UDI-Public: (01)15019517184204(17)290601(10)6019866
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2025

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: 21-7044-24
• Device Lot Number: 6019866
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 02/14/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/19/2024; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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