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

Model Number 1400

Device Problems Excess Flow or Over-Infusion (1311); Device Handling Problem (3265)

Patient Problem Overdose (1988)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that an infusion pump was in use with a patient in the morning when it was noted that the patient hit the pump with their arm.It was observed that the pump display showed "dose" before returning to normal operation.It was noted that the patient was unable to select the "input/reset" button.Due to the incident, it was suspected that there was a possibility of overdose.No patient injury was reported.

• 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
• 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: 7042772
• MDR Text Key: 93062420
• Report Number: 3012307300-2017-02394
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-09
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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