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

Model Number 1400

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  malfunction  

Event Description

Information was received indicating that a patient passed away "last month." per reporter the facility had a spare smiths medical cadd-legacy duodopa ambulatory infusion pump that was faulty; the fault was unspecified and reported indicated they were "unaware of fault." follow up was made to reporter to advise if the reported fault may have caused or contributed to the patient's death.Per reporter, "no additional information has been provided yet.".

Manufacturer Narrative

Other text: device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed the pump was in good condition.Review of the event history log showed occurrences of last error code 1260, 1210 and service due 60.The investigation confirmed the reported problem and determined that fluid ingression was the cause of the reported issue.

• Brand Name: CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11398486
• MDR Text Key: 234232301
• Report Number: 3012307300-2021-01652
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• PMA/PMN Number: 13215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death