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

Model Number 1400

Device Problems Device Alarm System (1012); Failure To Adhere Or Bond (1031); Failure to Infuse (2340)

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

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received indicating that a smiths medical cadd-legacy® duodopa pump continues to alarm with an error message that reads "no disposable, pump won't run, and advised the cassette may be not properly attached.The patient changed out batteries and reattached the cassette but is still unsuccessful with continuous alarm.A second cassette was reattached but unsuccessful.Subsequently, the following day, the patient was required to go to the hospital to help manage care.No further adverse effects were reported.

• Brand Name: CADD-LEGACY® DUODOPA 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7354850
• MDR Text Key: 102951433
• Report Number: 3012307300-2018-00580
• 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
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization