MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL CADD-LEGACY 1

Model Number 6400

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Issue With Displayed Error Message (2967)

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

Event Date 01/04/2017

Event Type  malfunction  

Event Description

Pt reports that his cadd legacy pump (b)(4) alarmed that the reservoir was empty while he was infusing, but the cassette was about 2/3 full.He switched to his other pump and the infusion resumed with no problem.Replacement pump to be shipped for delivery tomorrow am.Pt did not experience any adverse event related to the pump malfunction.Dose or amount: veletri 23.6 nkm, frequency: continuous, route: iv.Dates of use: (b)(6) 2016 to present.(b)(4).

• Brand Name: CADD-LEGACY 1
• Type of Device: CADD-LEGACY 1
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL; st. paul MN
• MDR Report Key: 6232407
• MDR Text Key: 64288742
• Report Number: MW5067087
• Device Sequence Number: 1
• Product Code: LZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR