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

Catalog Number 004192

Device Problems Increase in Pressure (1491); Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Information was received that a smiths medical tandem cleo 90 infusion set was in use with a patient for three days when their pump alarmed for an occlusion a couple of times (alarm 26).The patient's bgs were noted to be 420 mg/dl at the time of the event.Therefore, a correction bolus of humalog was delivered and the infusion set was changed out to resume insulin therapy.However, it was also reported that the patient's bgs were high, they experienced dka, and they were hospitalized.While hospitalized, the patient received an insulin drip and was released in stable condition with no permanent damage the following day.The reporter additionally stated the patient has been using their pump for insulin therapy successfully since.No additional adverse patient effects were reported.

Manufacturer Narrative

H3: the tandem cleo infusion set was not returned.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.Due to the fact that no lots of p/n 004192 were scheduled to be manufactured in the near future, a review of the manufacturing process for p/n 21-7232-24, l/n 3919795 was conducted by quality engineer in order to verify that there are no situations or practices that could create the event as described in "description of non-conformance".A review of the production floor inventory was conducted, a sample of 32 units from p/n 21-7232-24, l/n 3919795 to ensure that the cannula and the base does not present any damage that could cause an occlusion; no discrepancies were found.Four (4) samples of the production floor inventory were taken to perform test.Buckle was connected to the base and a syringe was used to pass water through the tube; no occlusion/blockage was detected.No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.

• Brand Name: TANDEM CLEO 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9555616
• MDR Text Key: 173847045
• Report Number: 3012307300-2020-00036
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 004192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVEL 1 TRAUMA FAST FLOW PRESSURE CUFF; LEVEL 1 TRAUMA FAST FLOW PRESSURE CUFF
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 20 YR