MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY CONTINUOUS INFUSION PUMP

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

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

Event Date 06/16/2016

Event Type  malfunction  

Event Description

Patient stated that when she turned on the pump in question, it started to beep and gave message "service maintenance due".Patient stated that she pressed the stop button thrice, and this took care of the beeping.She went on to use that pump and states that it has worked fine with no issues.Patient was informed that a new pump will be sent to her for delivery tomorrow, (b)(6) 2016.A return box will also be sent to the patient so the malfunctioning pump can be returned.The pump was not in use at the time the malfunction occurred, and patient had no side effects associated with the pump malfunction.Sn of pump: (b)(4).Dates of use: from (b)(6) 2016 to ongoing.Diagnosis or reason for use: i27.0.

• Brand Name: CADD LEGACY CONTINUOUS INFUSION PUMP
• Type of Device: CADD LEGACY
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• MDR Report Key: 6053604
• MDR Text Key: 58402976
• Report Number: MW5065569
• Device Sequence Number: 1
• Product Code: LZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/16/2016

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: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR