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

Model Number 1400

Device Problems Use of Incorrect Control/Treatment Settings (1126); Excess Flow or Over-Infusion (1311); Inadequate or Insufficient Training (1643)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.The retuned pump did not display any errors on power up, in the error log; and no unusual messages were found in the event history log.The event history log showed that the pump's delivery rate was previously at 9 ml/hr and was changed to 3ml/hr and set to lock level 1 which would then prevent additional rate increases.The pump passed all tests and was found to be working properly.

Event Description

Information was received indicating that the continuous day rate on a smiths medical cadd-legacy duodopa ambulatory infusion pump was "accidentally programmed and saved to 9 ml/h instead of 3 ml/h." per reporter, the approximate volume that accidentally was infused was unknown.It was reported that no medical treatment was provided, the dosage was subsequently corrected, and patient's wife was re-trained.No adverse effects were 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada ave. n.; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 9938333
• MDR Text Key: 187035606
• Report Number: 3012307300-2020-02870
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 21-1400-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1