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

Model Number 1400

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 04/27/2018

Event Type  Injury  

Event Description

It was reported that the patient's daughter had started the pump at 7:00 am.At 8:00 am during the psp nurse review it was found that md had not been administered (they had not pressed the md button twice).Md was administered immediately.From 9:00 am to 9:30 am, the patient became hyperactive and with little overstimulation and hallucinations.The patient was briefed by the treating physician.Also blood tests and abdominal x-ray were performed.All the examinations were ok and the patient was discharged from the clinic.After the daughter's concern and in consultation with the physician of the near public hospital the patient was admitted to (b)(6) hospital for further medical assessment.The customer classifies complaint as use error.Both the patient and her daughter did not allege that the device may have caused or contributed to any of the patient injuries or to any of the medical intervention.

• Brand Name: CADD-LEGACY DUODOPA
• 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 ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7537107
• MDR Text Key: 109017612
• Report Number: 3012307300-2018-01742
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Home Health Aide
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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
• Treatment: LEVODOPA/CARBIDOPA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR