MAUDE Adverse Event Report: SMITHS MEDICAL CADD-MS3; SET, ADMINISTRATION

Model Number MS3

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591)

Patient Problem Dizziness (2194)

Event Date 02/27/2017

Event Type  malfunction  

Event Description

Patient states pump alarmed blockage detected and also stated there were 10 hours remaining in the pump.However, the cartridge was empty and there were no signs of leakage.Sending replacement pump.Patient did experience dizziness, light headed, and off balance.Dose or amount: 0.028ml/hr.Frequency: continous.Route: sq.Dates of use: first ship (b)(6) 2017.Diagnosis: pah.Did the reported product fault occur while in use with the patient: yes.Did the product issue cause or contribute to patient or clinical injury: yes.If yes, was any medical intervention provided please explain: no, symptoms resolved once medication restarted.

• Brand Name: CADD-MS3
• Type of Device: SET, ADMINISTRATION
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6376127
• MDR Text Key: 69154069
• Report Number: MW5068248
• Device Sequence Number: 1
• Product Code: FRN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MS3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1