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

Catalog Number 21-7220-24

Device Problem Defective Device (2588)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2017-01997, 3012307300-2017-02035, 3012307300-2017-02037, 3012307300-2017-02038, 3012307300-2017-02039, 3012307300-2017-02040, 3012307300-2017-020341, 3012307300-2017-02042, 3012307300-2017-02043.(b)(4).

Event Description

It was reported that there were site issues with a cleo® 90 infusion set.The patient's blood glucose levels were 33.3 mmol at the time of the event.There were no alarms indicating rising blood glucose levels.The patient also experienced vomiting, and visited the hospital.A problem with the patient's pump was ruled out as the pump was "working fine".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: 6852856
• MDR Text Key: 85442642
• Report Number: 3012307300-2017-02036
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/02/2022
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 77X028
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 9 YR