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

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331731198
• Report Number: 9617604-2023-00040
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: 10610586044748
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CADD PUMP.