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

Catalog Number 004192

Device Problem Material Twisted/Bent (2981)

Patient Problems Electrolyte Imbalance (2196); Diabetic Ketoacidosis (2364)

Event Date 05/29/2019

Event Type  Injury  

Event Description

Information was received indicating that the patient was admitted to the hospital after coming in for diabetic ketoacidosis.The patient's blood glucose level was 534mg/dl when she arrived to the emergency room.The patient reported that she was using the cadd cleo infusion set for a week at the time of the hospitalization.She reported that the cannula was bent or blocked and was unable to change it out because she did not have a replacement.The patient received an insulin drip to resolve the issue and reported that her blood glucose levels are now back to normal.

• 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: 8918595
• MDR Text Key: 155168987
• Report Number: 3012307300-2019-04135
• 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

• 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
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/21/2019
• 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: 32 YR