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

Model Number 1400

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dyspnea (1816); Overdose (1988); Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 11/02/2020

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump may have been used erroneously with a morphine cassette.The reporter was unable to confirm the pump number or that a duodopa pump was used with the morphine cassette.It was reported that "the nurse/reporter cannot understand that the patient had any other pump, it must have been the duodopa pump that was connected to the morphine cassette." per reporter the admission note from the hospital stated "this is a patient with advanced parkinson's disease with a morphine pump." reporter states patient's wife "has never seen any pump other than a duodopa pump but nurse/reporter cannot with 100% certainty say that it was a duodopa pump, even if she cannot understand anything else and therefore thinks that the emergency room incorrectly has written morphine pump in the note." it was reported that the morphine cassette was "most likely destructed" and it was difficult to find information about it.It was reported that the cassette was marked with another patient's name and date of birth.Per reporter when the patient was at nursing home a nurse made a mistake and used a morphine cassette belonging to another patient on the pump.Per reporter the patient's duadopa pump was programmed with 11 ml as his morning dose.It was "unknown if the same dose of morphine was administered." per reporter the morphine cassette was connected at 6 am, the patient was "observed after 2 hours, at 9 am the ambulance was called, respiratory arrest, chest compressions were performed." it was reported patient was "cyanotic and not contactable." patient was taken to hospital emergency room.Per reporter the hospital admission note stated: "wrong treatment with morphine in large doses." it was reported that the cassette was "replaced immediately and a neuro patch attached (dopamine agonist patch)." it was reported that subsequently the patient was "placed under observation as he was not perceived as stable, received non-invasive ventilation(niv) treatment, had difficulty breathing and also due to a lot of pain due to rib fractures.The patient received two types of antibiotics: tazocin and cefotaxim, due to bilateral pneumonia.During admission, the patient was also tube fed some.Due to severe pain the patient received oxytocin and fentanyl pain patches." patient was subsequently discharged to nursing home but admitted again to hospital due to being unable to urinate.".

• 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10950095
• MDR Text Key: 219840481
• Report Number: 3012307300-2020-12124
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention