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

Catalog Number 21-7231-24

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905)

Event Date 03/17/2017

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.Date of therapy reported as "(b)(6) 201".

Event Description

It was reported that during a change of the cleo® 90 infusion set, the patient observed bleeding at the infusion site.The patient reported that they began to notice the blood at the infusion site after their health care personnel (hcp) changed and increased their medication dosage on (b)(6).The medication was changed to mirtazapine.The blood at the infusion site had resulted in a blockage of the infusion site and blood within in the infusion set tubing.According to the report, the patient blood glucose level was 273 mg/dl at the time of the event; the patient did not have ketones.To resolve their high blood glucose levels, the patient changed their plastic cannula infusion set to a steel cannula infusion set and delivered an insulin bolus with the infusion pump.The patient reported that they did not observe any damaged when the infusion set package was first opened; however, the adhesive of the infusion set would be removed with the infusion set cap.Additionally, it was reported that the patient experienced "contact detach" with the infusion set.The patient reported that they will discuss their medication with their hcp as they believe blood thinning may be a possible side effect of the new medication and increased dosage.No permanent adverse effects to patient reported.Related mfr #'s: 3012307300-2017-00841, 3012307300-2017-00842, 3012307300-2017-00843, 3012307300-2017-00844, 3012307300-2017-00845.

Event Description

It was further reported that the patient observed bleeding at the infusion site after the cannula was removed.The patient reported that when the device was initially opened the infusion set adhesive was removed with the infusion set cap.The patient stated that they used iv medical tape to secure the infusion site and continued to use the infusion site.

• 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, b.c 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6487554
• MDR Text Key: 72652362
• Report Number: 3012307300-2017-00840
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2021
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 76X175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• 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
• Treatment: MIRTAZAPINE
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR