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

Catalog Number 21-7220-24

Device Problems Device Alarm System (1012); Failure to Infuse (2340)

Patient Problems Hyperglycemia (1905); Nausea (1970); Weakness (2145)

Event Date 11/04/2018

Event Type  Injury  

Event Description

Information was received indicating that insulin was not infusing through a smiths medical cleo® 90 infusion set after the site being changed 1-2 days prior.The patient states that they woke during the night, feeling weak and nausea's, with blood sugar level of 510 despite trying to correct the level for over an hour.The infusion set was changed out and a corrective bolus was re-administered, bringing blood glucose down.Reported that no occlusion alarm prior to changing the site.The patient recovered with no further adverse effects.

Manufacturer Narrative

Date of event: (b)(6) 2017.

Manufacturer Narrative

Five cleo sets were received.The returned samples were received in used conditions inside a plastic bag without their original packaging.The samples were visually inspected, at a distance of 12" to 24" and normal conditions of illumination.Visual inspection revealed the following.Three of the samples were received used and without abnormalities, one sample was received with the cannula detached, and one sample was received with the septum white pad removed.The samples were tested using an infusion set to replicate the failure mode.No occlusion was detected during the testing, the water passed through the all septums.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this 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 MANUFACTURING; s.a. de c.v.; a d no.4 parque industrial int; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7283044
• MDR Text Key: 100454545
• Report Number: 3012307300-2018-00325
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7220-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 31 YR
• Patient Weight: 61