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

Model Number 21-7600-24

Device Problem Volume Accuracy Problem (1675)

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

Event Type  malfunction  

Manufacturer Narrative

Accuracy test: the sample received was connected to the cadd legacy plus cal.Id: (b)(4); due date: september 2021 and to balance mettler toledo cal.Id:1.0386; due date: january 2022 to look for unusual function.Results: sample was fully priming and connected without difficult, the pump was set running and the alarm was not activated.The cassette passed the test.The complaint is not confirmed.Root cause: no root cause could be determined due complaint was not confirmed.Actions taken: no actions taken due complaint was not confirmed.

Event Description

It was reported that during the use of the product (a medication cassette), the customer noticed there was more than 6% of discrepancy between the programmed value of the cadd legacy pca pump and the actually remaining amount of medical fluid.No patient injury was reported.

• Brand Name: NRFIT
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13361710
• MDR Text Key: 286501866
• Report Number: 3012307300-2022-01832
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044007
• UDI-Public: 10610586044007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7600-24
• Device Catalogue Number: 21-7600-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1