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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dizziness (2194); Reaction to Medicinal Component of Device (4574)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

D4 and g5 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 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.

Event Description

It was reported that the patient noticed that the last few tubings had medication leaking.The patient experience congestion and lightheadedness while using new tubing from latest dispense, possibly due to the higher dose of medicine administered through intact tubing.The patient was advised to restart at half the pump rate and titrate back to maintenance rate as tolerated.The patient was advised to contact medical doctor md if symptoms persist.No medical or surgical intervention was reported.Additional information received via email: product part and lot number are unknown and not provided.The event occurred while pump in use with patient.Cvs does not complete paperwork, all information provided in the body of email.Date of event, patient information provided and complaint updated.The event resolved.The team reached out to patient to confirm if product was available for return.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16727817
• MDR Text Key: 313165433
• Report Number: 3012307300-2023-04039
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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: 03/06/2023
• 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
• Patient Age: 42 YR
• Patient Sex: Female