MAUDE Adverse Event Report: SMITHS MEDICAL CADD; LEGACY

Lot Number SN338017

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 12/08/2016

Event Type  malfunction  

Event Description

Patient stated that cadd legacy pump beeps consistently with "high pressure" on the unit.The pump could not be trouble-shooted over the phone.No interruptions in therapy.Replaced pump.Dates of use: from (b)(6) 2016.Diagnosis or reason for use: pah.

• Brand Name: CADD
• Type of Device: LEGACY
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• MDR Report Key: 6185402
• MDR Text Key: 62863927
• Report Number: MW5066748
• 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: 12/08/2016

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: No Information
• Device Expiration Date: 01/27/2014
• Device Lot Number: SN338017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR