MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. NRFIT, SET, ADMIN, SPIKE, TOTM, FS, YELLOW, BCV, 12/BX; SET, I.V. FLUID TRANSFER

Catalog Number	21-7624-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the pump exhibited an upstream occlusion alarm, and the epidural analgesic injection was stopped due to the alarm that involved multiple patients.No occlusion was noted.No patient injury was reported.
Additional Manufacturer Narrative
One sample was returned for evaluation.Visual inspection revealed no discrepancies.During functional testing, no discrepancies were found.The failure mode was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: NRFIT, SET, ADMIN, SPIKE, TOTM, FS, YELLOW, BCV, 12/BX
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18405524
• Report Number: 9617604-2023-00040
• Device Sequence Number: 19566369
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: 10610586044748
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: Lay User/Patient
• Device Expiration Date: 11/10/2024
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 4339181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD PUMP.
• Patient Sex: Unknown