MAUDE Adverse Event Report: SMITHS MEDICAL CADD SOLIS AMBULATORY INFUSION PUMP; MEA - PUMP, INFUSION, PCA

Model Number 2100

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problems Chest Pain (1776); Death (1802); Tachycardia (2095)

Event Date 02/25/2015

Event Type  Death  

Event Description

According to reporter, the pt was undergoing cancer treatment.On date of event, pt's implanted access system was surgically removed and replaced.Following surgery, pt was admitted to hospital the followings day with tachycardia (170 to 175 bpm) and chest pain.Pt was given pain medication using an infusion pump (programmed to deliver 1.5 mg of hydromorphone per hr with 2 mg every 30 minutes as needed: drug concentration of 2mg/ml).Pt expired on (b)(6); cause of death has not been provided.According to reporter, it was later identified that the infusion tubing had not been unclamped by the nurse during set up.No pump alarms were reported to have occurred during infusion.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Manufacturer Narrative

(b)(4).Manufacturer narrative: the device was returned for evaluation.The returned pump was given functional testing: a filled medication cassette reservoir was attached to the pump with a closed clamp.Shortly after the test infusion was started, the pump alarmed and displayed "downstream occlusion.Clear occlusion between pump and patient." the device performed as expected during testing of the occlusion sensor.The returned pump was given downstream occlusion sensor testing three additional times.During this testing, the sensor was found to activate within device's pressure limit specifications and trigger the pump alarm as expected.The device's event history log was downloaded and reviewed for the date of reported event ((b)(6)).No unusual events were noted during this time.The returned pump was found to meet with functional and delivery specifications.The reported issue could not be confirmed during testing.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Type of Device: MEA - PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• Manufacturer (Section G): SMITHS MEDICAL; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4838039
• MDR Text Key: 5914366
• Report Number: 2183502-2015-00403
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2100
• Device Catalogue Number: 21-2120-0100-50
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/25/2015
• Date Manufacturer Received: 03/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death