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

Model Number 1400

Device Problems Device Alarm System (1012); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is same and/or similar to a device approved for distribution in the us.One used cadd-legacy® duodopa pump was received for investigation.Through visual inspection, it was confirmed that the pump's battery door was difficult to operate as a result of contamination from a leaking battery.A root cause for the leaking battery could not be determined.

Event Description

It was reported that the patient's wife could not replace the batteries of a cadd-legacy® duodopa pump because the battery compartment would not open.The pump displayed a "batteries low" message.It was reported that the patient fell "some time ago", and wondered if the fall could be linked to the error message.The patient's wife later reported that the pump gave an alarm with three tunes every five minutes.It is unclear whether that alarm was a high pressure alarm or a low battery alarm.The patient's wife still was unable to open the compartment to replace the batteries, however, the pump still displayed "running".The patient's wife later reported the same issue; low batteries, compartment stuck, pump running.The patient was provided with a new pump.No injury was 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 north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7434343
• MDR Text Key: 105683919
• Report Number: 3012307300-2018-01276
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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
• Patient Age: 78 YR