MAUDE Adverse Event Report: SMITHS MEDICAL CADD PUMP; LEGACY

Lot Number SN338108

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

Patient states that the pump she received on (b)(6) 2016 has had issues since she's gotten it.Patient states that the beeping doesn't stop, no matter what she and her daughter tried, and the error messages vary.Counseled patient on the importance of always having a working back-up pump, and to notify pharmacy immediately anytime she has pump issues so that they can be resolved asap.Patient v/u.No other questions/concerns.Dose or amount: remodulin 33.75 mcg.Frequency: continuous.Route: iv.Dates of use: from (b)(6) 2015 to present.Diagnosis or reason for use: pah.

• Brand Name: CADD PUMP
• Type of Device: LEGACY
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 5586805
• MDR Text Key: 43043502
• Report Number: MW5061756
• Device Sequence Number: 1
• Product Code: LZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2016

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: 03/17/2017
• Device Lot Number: SN338108
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR