MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CADD® CADD-LEGACY® PCA PUMP; PUMP, INFUSION, PCA

Catalog Number 21-6300-02

Device Problem Use of Device Problem (1670)

Patient Problems Aneurysm (1708); Ischemia (1942); Overdose (1988); Anxiety (2328)

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is event occurred in (b)(6).The customer sent the cadd-legacy pump into technical service (b)(6) with documentation that indicated that the pump possibly contributed with a treatment adminstration error.Additional information was received and it was reported that the nurse made a programming error (10mg/ml instead of 1mg/ml of morphine) causing morphine over infusion.It was stated that an abdominal aneurysm could be the consequence of the incident.Due to mesenteric ischemia a section of the small intestine was removed.No operative sequelae occurred but the patient was still hospitalized as of (b)(6) 2016.It was reported that the patient was given midazolam for anxiousness.Additional information has been requested on the patient outcome.

Manufacturer Narrative

The reported cadd legacy pca pump was returned to smiths medical for investigation of over infusion and possible programing error.Pump alarm sensors were verified and were found to be functional and within specification.The pump delivery accuracy was checked and found to be measured within smiths system delivery accuracy specification.A review of the pump history log finds that the period of events recorded by the pump start on (b)(6) 2016 10:59 am and continue through (b)(6) 2016 2:41 pm.The "incident report" form does not state when the alleged incident occurred.Review of the log shows the stated change to the concentration record from 10mg/ml to 1mg/ml.The record shows that the concentration change occurred on (b)(6) 2016 2:56 am.Indications are that prior to (b)(6) 2016 2:56 am all infusions would be at the previous concentration.Date and time of initial concentration setting is not recorded in the history log.

Event Description

It was reported that on 09-sep-16, notification was received that the patient expired.Cause and time of death was not reported.Additional information was requested but not yet received.

• Brand Name: CADD® CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL OAKDALE; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5848411
• MDR Text Key: 51223958
• Report Number: 2183502-2016-01666
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Disability