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

Catalog Number	21-7323-24
Medical Device Problem Codes	Failure to Prime (1492); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned for root cause analysis.Complaint for the failure mode "a0392 - priming difficulty." could not be confirmed.In photo provided by the customer, it is not possible to see the defect.Without the return of the samples, a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.
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 the pump will not prime.Per reporter, the nurse tried several sets, and an engineer was called in to examine the pump that was not priming correctly.Despite trying multiple new cassettes, the unit continued to display an occlusion alarm.It was noted that the set might differ slightly from the previous lot number.He tested the unit with his own test set, which worked correctly, indicating that the issue might be related to the current lot number being used.The event occurred during post procedure.There was no patient involvement.

• Brand Name: CADD ADMINISTRATION 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: 20663811
• Report Number: 3012307300-2024-13148
• Device Sequence Number: 15256713
• Product Code: FPA
• UDI-Device Identifier: 10610586039614
• UDI-Public: (01)10610586039614(17)281012(10)4434303
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Catalogue Number: 21-7323-24
• Device Lot Number: 4434303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown