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

Model Number 1400

Device Problem Delivery System Failure (2905)

Patient Problem Loss of consciousness (2418)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a cadd® cadd-legacy® pca pump stopped working at some stage during the night.The patient's spouse set up the second pump and commenced the morning dose.The patient was breathing and had a pulse, but was non-responsive.The spouse was advised to call 999.No further information was gathered on the pump error due to the need for urgent medical attention.No further information was gathered on the outcome of the patient.

Manufacturer Narrative

One cadd-legacy® duodopa pump was returned for analysis in good condition.The customer reported problem was "delivery accuracy".Inspection of the pump's event log showed that all requested doses were recorded and completed.No errors recorded.The customer's concern of residual fluid remaining was unable to be confirmed following delivery accuracy testing, sensor verification, and event log review.The delivery accuracy testing found the pump to have a slight positive delivery but well within the published specifications.The cause of the failure is unknown.No fault was found.

• Brand Name: CADD® CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7133527
• MDR Text Key: 95341337
• Report Number: 3012307300-2017-02701
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARBIDOPA; LEVODOPA
• Patient Outcome(s): Required Intervention