MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACYPUMP; CADD LEGACY PUMP

Model Number 6400

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/12/2017

Event Type  malfunction  

Event Description

Patient's pump was alarming and would not display any error message.No other information available.Dose or amount: veletri 9.5 ng/kg/min.Frequency: continuous.Route: iv.Dates of use: (b)(6) 2017 to present.Diagnosis or reason for use: pah.

• Brand Name: CADD LEGACYPUMP
• Type of Device: CADD LEGACY PUMP
• Manufacturer (Section D): SMITHS MEDICAL ; st. paul MN
• MDR Report Key: 6647114
• MDR Text Key: 77841237
• Report Number: MW5070456
• 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: 06/12/2017

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: 06/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR