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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2017-02068.

Event Description

It was reported that the patient's pump alarmed for occlusion (alarm number in pump history: 2) during use of a cleo® 90 infusion set.The patient had tried changing out their tubing following the occlusion alarm, but occlusions continued.It was noted the patient wears a pump in a case in their pocket.The occlusion occurred during bolus delivery.The patient's blood glucose level was 145mg/dl at the time of the event.The patient had been using their cartridge/infusion set for less than three days.A soft cannula was used with the infusion set.The patient's cartridge was noted to be overfilled with insulin.The patient was advised to change their site.The patient also noted there was dried blood and bruising on their skin.After changing the site, the patient reported no further occlusions.No permanent injury was reported.

• 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, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6889976
• MDR Text Key: 87198118
• Report Number: 3012307300-2017-02069
• 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
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOVOLOG INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR