MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-MS3; PUMP, INFUSION

Model Number 7400

Device Problem Image Display Error/Artifact (1304)

Patient Problem Irritation (1941)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Patient states that she gets "sore" where the hy-tape is being placed ("feels like how a bruise feels").Patient also states that ms3 pump sn #(b)(4).Maintenance due date 09/13/20 has a problem with the screen.Patient states that the pump is working, but half the screen is not visible so hard to program.Sending replacement pump and other tapes for patient to try, will not notify md.See next patient for further device information.Did this reported product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? yes.Did we replace device? yes.Report to (b)(6) by: patient/caregiver.

• Brand Name: CADD-MS3
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 9291100
• MDR Text Key: 165775392
• Report Number: MW5090941
• Device Sequence Number: 1
• Product Code: FRN
• 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: 10/18/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2020
• Device Model Number: 7400
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR