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

Model Number	21-7624-24
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer did not provide the lot number of the affected device.
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that during the use of the product, an occlusion alarm sounded.After the user changed the cassette to another one, the alarm was settled.There was no patient injury.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection: no occlusions nor obstructions were detected on the samples.Functional test: the complaints sample was tested using the cadd pump solis [cal.Id: 1.0326; due date: august, 2021] to prime the devices as instruction of use as10003589-004 rev.100 indicate.No difficulty were detected during the priming and no alarms were activated, the water could pass through the whole devices; thus the failure mode reported is not confirmed.The cause of the reported problem could not be determined.No corrective actions are required since the complaint was not confirmed.

• Brand Name: NRFIT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: david halverson ; 6000 nathan lane north; 2-12-12 kitanagase-omotemachi,; minneapolis, MN 55442
• MDR Report Key: 11729810
• Report Number: 3012307300-2021-03478
• Device Sequence Number: 3833235
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: 10610586044748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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 Model Number: 21-7624-24
• Device Catalogue Number: 21-7624-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown