MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7609-24

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Event Description

Information was received indicating that over delivery of medication was observed while using the cadd cassette reservoirs - flow stop.An "air in line detected" alarm sounded, and the customer tried to administer another medical fluid to the patient.At that time, it was noted that the medication bag was empty.However, the remaining amount indicated on the pump's display was about 22 ml.There were no adverse events reported.

Manufacturer Narrative

Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.A manufacturing dhr review was not performed because a lot number was not provided.

• Brand Name: NRFIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11169823
• MDR Text Key: 226791901
• Report Number: 3012307300-2021-00412
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• Combination Product (y/n): N
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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: No Information
• Device Model Number: 21-7609-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 04/18/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1