MAUDE Adverse Event Report: SMITH MEDICAL CADD-LEGACY 1; LEGACY PUMP

Model Number 6400

Device Problems Device Maintenance Issue (1379); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 03/12/2016

Event Type  malfunction  

Event Description

Patient advised one of her pumps malfunctioned over the weekend, sn (b)(4) due back for maintenance on (b)(6) 2016.Alarmed with code indicating it was due for service.Patient is using her back up pump and infusing.Advised we would send replacement pump and reminded patient to call pharmacy right away with any pump issues.No other information provided.Dose or amount: 118ng/kg/min.Frequency: continuous.Route: iv.Dates of use: from (b)(6) 2012 to current.Diagnosis or reason for use: i27.0.

• Brand Name: CADD-LEGACY 1
• Type of Device: LEGACY PUMP
• Manufacturer (Section D): SMITH MEDICAL
• MDR Report Key: 5510712
• MDR Text Key: 40784569
• Report Number: MW5060941
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 6400
• Device Lot Number: 2100701
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR