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

Model Number 1400

Device Problems Improper or Incorrect Procedure or Method (2017); Fail-Safe Did Not Operate (4046)

Patient Problem Sleep Dysfunction (2517)

Event Date 06/01/2018

Event Type  Injury  

Event Description

It was reported that a patient had now been altogether in three different hospitals in three weeks.The patient was originally hospitalized for troubles with breathing and water in the lungs.The hospitalization has been prolonged and the patient's spouse thinks this is due to the hospitals not been able to take care of the patient's duodopa medication by use of a cadd® cadd-legacy® duodopa pump.The spouse states that several morning doses were missed in the first hospital.All of the morning doses were missed at the second hospital for a week.The patient's condition is miserable and one day the patient could not be woken up.The third hospital had only one cassette of duodopa and it had been in use for a long time.The third hospital also missed morning doses.In the notes by the nurses, it had said that the morning dose had been administered, but when the spouse had pressed the button, the device had started to administer a morning dose, although there was a 20h time-lock.Other reports from the nursing staff state the morning doses had been given at odd times.There were no reports of any other adverse effects.

• Brand Name: CADD® 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.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7727701
• MDR Text Key: 115271240
• Report Number: 3012307300-2017-02992
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2018
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: CARBIDOPA; LEVODOPA
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR