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  

Event Description

It was reported that an under delivery of medical fluid was observed during the use of the product.No patient injury.No patient injury was reported.

Manufacturer Narrative

Accuracy test: the sample received was connected to the (b)(6) cal.Id: 1.0386; due date: september 2021 and to balance mettler toledo cal.Id: 35.0019; due date: january 2022 to look for unusual function.Results: sample was fully priming and connected without difficulty, the pump was set running and the alarm was not activated.The cassette failed the test.The complaint is confirmed.Root cause: per trend review in delivery accuracy complaint code an escalation was performed to investigate this failure and determine the root cause for delivery issues.Escalation was initiated on (b)(6) 2021 under capa (b)(4).Actions taken: by the date capa (b)(4) is in implementation phase.All occurrence and detection mitigations are placed in process.

• 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: 13361588
• MDR Text Key: 286565882
• Report Number: 3012307300-2022-01821
• 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,User Facility
• 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

• 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: 07/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 01/26/2022
• 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