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

Model Number 6400

Device Problems Failure to Prime (1492); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2002

Event Type  malfunction  

Event Description

Pump will not prime or infuse.Unable to troubleshoot.Will replace pump.No other info known.Reported by pt's caregiver.The reported product fault occurred while in use with a pt.The product issue did not cause or contribute to pt or clinical injury.Sn: (b)(4).Dose or amount: 81 nkm, frequency: continuous, route: iv.Dates of use: from (b)(6) 2015 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACY
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7689366
• MDR Text Key: 114142083
• Report Number: MW5078413
• Device Sequence Number: 1
• Product Code: FRN
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 6400
• Was Device Available for Evaluation?: Yes
• 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: 47 YR