MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7400

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Per patient cadd ms3 pump with serial number (b)(4) lost programming and patient stated one of her cleo tubing would not detach from the cannula and had to use it for 3 mixes, possible lot number could be 4063676.Patient did not report any side effects and does not have the defective tubing on hand did the reported product fault occur while in use with the patient? pump no/ tubing yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? pump yes/tubing no.Did we replace device? yes.Did the patient have a backup device they were able t switch to? yes if yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Reported to (b)(4) by pt/caregiver.

• Brand Name: INF SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14195569
• MDR Text Key: 290118848
• Report Number: MW5109338
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7400
• Device Lot Number: 4063676
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CADD PUMP MS3
• Patient Sex: Female