MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S. A. DE C. V. CADD MS3; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

S/w, pt's son regarding scr ms3 pump.States sn# 455735 isn't showing all options as it usually does - "start delivery" isn't showing, and pt's son tried resetting options as he usually does.Advised a replacement pump will be sent - this pump was not on pt, was the pump that pt was going to switch to for next cartridge change.The reported product fault did not occur while in use with a pt.The product issue did not cause or contribute to pt or clinical injury.We replaced the device.Dates of use: from (b)(6) 2017 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: CADD MS3
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S. A. DE C. V.
• MDR Report Key: 7851184
• MDR Text Key: 119645265
• Report Number: MW5079643
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Patient Age: 78 YR