MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CLEO INFUSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 004192

Device Problem Obstruction of Flow (2423)

Patient Problem Electrolyte Imbalance (2196)

Event Date 07/22/2019

Event Type  Injury  

Event Description

Information was received indicating that the patient's blood glucose level was 525mg/dl.The reason for the elevated blood glucose is believed to be due an occlusion of the cadd cleo infusion set.The patient was using a soft cannula and it's believed that there was a blockage at the site.A manual dose injection was used to correct the blood glucose level.To resolve the issue further, the customer will be changing the injection to a new site to resume the insulin injection.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneaplois, MN 55442 ; 7633833310
• MDR Report Key: 8918597
• MDR Text Key: 155170107
• Report Number: 3012307300-2019-04133
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028407
• UDI-Public: 30610586028407
• 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
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 004192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR