MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION; SET, I.V. FLUID TRANSFER

Catalog Number	21-7605-24
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump alarmed, "blockage and no flow," and the tube orientation was checked.Per reporter, this occurred during priming at the facility.There was no patient involvement.No patient harm/adverse event reported.
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
One unit received without its original packaging, in decontaminated conditions.The sample was visually inspected, and no damage or other defects were detected on the sample.Functional testing of the sample was not able to duplicate the customer reported issue.The investigation was not able to determine a cause of the customer reported issue.No non-conformities were found in the device history review.

• Brand Name: CADD EXTENSION
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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: 19655262
• Report Number: 3012307300-2024-05549
• Device Sequence Number: 17828915
• Product Code: LHI
• UDI-Device Identifier: 10610586044113
• UDI-Public: (01)10610586044113(17)250821(10)4420041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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 Expiration Date: 08/21/2025
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 4420041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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