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

Model Number 21-7600-24

Device Problem Complete Blockage (1094)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to smiths/icu medical.

Event Description

It was reported that during the pre-use check, the customer noticed medical fluid would not pass through the product due to occlusion in it.No patient injury was reported.

Manufacturer Narrative

H6: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The device appeared to be in good physical condition.Upon function testing, the reported problem could not be duplicated.The root cause of the reported problem is unknown as the device was able to function properly.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-06731.The report was submitted in error.

• Brand Name: NRFIT CASSETTE
• 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): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 14161587
• MDR Text Key: 289678900
• Report Number: 3012307300-2022-06731
• 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,Followup,Followup
• Report Date: 05/10/2023

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 Expiration Date: 07/21/2023
• Device Model Number: 21-7600-24
• Device Catalogue Number: 21-7600-24
• Device Lot Number: 4168766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 09/28/2022; 05/04/2023
• Supplement Dates FDA Received: 10/19/2022; 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1