MAUDE Adverse Event Report: ST PAUL CLEO 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Connection Problem (2900)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Pain (1994)

Event Type  malfunction  

Event Description

It was reported that the patient was increasing every month now due to side effects (nausea, diarrhea, foot pain, and headaches).Patient reported an issue with infusion set last week, when it did not connect to the site correctly.The pump alarmed and delivery was stopped for 20 or 30 minutes.Patient was unsure if she was supposed to change cartridge in that situation, she changed cartridge and tubing.No other information available.Reported to by patient and /caregiver.No medical or surgical intervention was reported.Additional information received by smiths via email on 04 aug 2021: no device will be returned.The infusion set was attached incorrectly.Pump still in use.No other information provided.

Manufacturer Narrative

Device identification and protocol number are unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: CLEO 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16457724
• MDR Text Key: 310421326
• Report Number: 3012307300-2023-01789
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• 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
• Patient Sequence Number: 1