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

Model Number	7060
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: 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 the blockage alarm did not sound.Even if the operator changed the instrument, it did not sound, and if the operator removed the extension tube from the cassette, it can prime, but the problem with the extension tube.The event occurred at the patient's home.This occurred during priming.There was no patient involvement.
Additional Manufacturer Narrative
D4.Lot#, expiration date, udi, h4.Mfg.Date - updated.One device was returned for analysis in used condition.Customer also provided 3 photos.No damage was detected during the visual inspection.Functional testing was performed.During the test, the distilled water did not pass through the assembly.The sample was found occluded.According to the functional test, the failure mode ¿a0348 - not working¿ was confirmed.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20334338
• Report Number: 3012307300-2024-10234
• Device Sequence Number: 20833972
• Product Code: FPA
• UDI-Device Identifier: 10610586020438
• UDI-Public: (01)10610586020438(17)270621(10)4301250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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 Model Number: 7060
• Device Catalogue Number: 21-7060-24
• Device Lot Number: 4301250
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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: CASSETTE LOT NUMBER: UNKNOWN.; INFUSION PUMP SN: UNKNOWN.
• Patient Sex: Unknown