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

Catalog Number	21-7052-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Infuse (2340); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that ¿patient (kn) maintaining a continuous prostacyclin infusion using the cadd solis/cassette, attempted to prime infusion line unattached ¿ as fluid advanced along the line, as it reached the in-line micron filter an occlusion alert ¿red screen flashing ¿ occlusion alarm¿ came up, attempts to re-prime were met with same and then blue strip on top of screen downstream occlusion cleared¿.The problem was fixed by changing the cassette.
Additional Manufacturer Narrative
(b)(6) a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Neither samples nor pictures were received for the analysis of this complaint.Complaint for the failure mode ""a0350 - occluded/blockage"" could not be confirmed by investigation as no samples nor pictures was provided by the customer.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.
Additional Manufacturer Narrative
Six units were received for evaluation in used condition.As received all six set were observed to have tears in the filter.A singular tear was observed at the air outlet of each filter.Functional testing was performed, and leakage was observed from the tear observed on the filters of all six sets, resulting in the inability to prime any of the sets.The customer reported issue was not confirmed.During investigation a tear that led to leakage at the air outlet portion of the filter was confirmed.The probable cause of the tear is unknown.

• Brand Name: CADD EXTENSION 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: 20304344
• Report Number: 3012307300-2024-09910
• Device Sequence Number: 18078868
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: (01)10610586020346(17)271209(10)4342624
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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: 21-7052-24
• Device Lot Number: 4342624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 11/14/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/14/2024; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD SOLIS PUMP; PROSTACYCLIN
• Patient Sex: Unknown