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

Model Number 1400

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received indicating that this ambulatory infusion pump was not operating as expected.It was noted that the medication cassettes appeared to be almost full after use indicating the pump was under delivering.This led to the patient being akinetic and feeling pain in their legs.The patient required hospitalization.The pump was exchanged and the patient began oral medication.No additional adverse patient effects were reported.

Manufacturer Narrative

One device was returned for evaluation.Visual inspection found the labels intact and the device in good condition.A review of the event history log found all dose requests were completed.Delivery accuracy and simulated use testing was performed and was unable to find any discrepancy or performance issues and was within manufacturing specifications.Based on the evidence, a root cause was unable to be determined.The pump passed all tests and was found to be operating properly.

• Brand Name: CADD® CADD-LEGACY® 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 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7158403
• MDR Text Key: 96183409
• Report Number: 3012307300-2018-00012
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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: LEVODOPA/CARBIDOPA
• Patient Outcome(s): Hospitalization