MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7220-24

Device Problems Bent (1059); Kinked (1339); Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 11/12/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a patient using a cleo® 90 infusion set, experienced high blood glucose due to a bent cannula.The patient's blood glucose level was "275" at the time.The report stated that the patient will be administered an insulin bolus to resolve their high blood glucose.During trouble shooting with the reporter, that the patient was requested to examine the infusion site and found that the cannula was bent.There was also a pump occlusion alarm 2 noted at 1:49 am.According to the reporter, the patient was requested to change out the infusion set, in order to deliver the corrected bolus to resolve their high blood glucose.The patient was further instructed to change supplies and resume insulin.

Manufacturer Narrative

Please note additional/corrected information: additional information was received from the initial reporter which stated that this file is a duplicate of mfr# 3012307300-2017-00021.As this file is a duplicate it is no longer considered a complaint and is therefore not a reportable event.

• Brand Name: CLEO® 90 INFUSION 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 HEALTHCARE MFG; s.a. de c.v. ave, calidad no.4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north, MN 55442 ; 7633833074
• MDR Report Key: 6228896
• MDR Text Key: 64051470
• Report Number: 3012307300-2017-00018
• Device Sequence Number: 1
• Product Code: FPA
• 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: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR