MAUDE Adverse Event Report: SMITH MEDICAL ASD, INC. CASSETTE CADD LEGACY MEDICATION RESERVOIR; PUMP, INFUSION

Device Problem Particulates (1451)

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

Event Date 11/11/2019

Event Type  malfunction  

Event Description

Spontaneous call from pt about cassette serial number (b)(4) / cadd legacy.(serial number (b)(4)) after mixing had particulate matter in it.Pt reported this was happened several times in past 2 weeks.No further info available.The pt did not experience an adverse event.Did the pt have a backup device they were able to switch to? yes.If yes, was the pt able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event ? resolved.Did the reported product fault occur while in use with a pt? no.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual device available for investigation? no.Did we replace the device? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE CADD LEGACY MEDICATION RESERVOIR
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITH MEDICAL ASD, INC. ; minneapolis MN
• MDR Report Key: 9342710
• MDR Text Key: 167229757
• Report Number: MW5091169
• 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: 11/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 26 YR