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

Model Number 21-7220-24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned.Production records were evaluated to ensure that production was up to standards.Quality audits the adhesion testing of the skin adhesive and the pull testing of tubing set, at start up and at least every (3) hours, in order to verify there are not abnormal behavior and have met within specification.No root cause could determinate since the complaint could not be confirmed since no samples or pictures were received for evaluation.

Event Description

Information was received indicating that a smiths medical cleo administration set was implicated in an issue of a patient having sepsis secondary to cellulitis.This resulted in hospitalization of the patient to treat the infection.No other reported adverse events.

• Brand Name: CLEO ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11011237
• MDR Text Key: 221508522
• Report Number: 3012307300-2020-12396
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2023
• Device Model Number: 21-7220-24
• Device Lot Number: 3676602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization