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

Model Number 1400

Device Problem Device Alarm System (1012)

Patient Problems Seizures (2063); Convulsion, Clonic (2222); Dyskinesia (2363)

Event Type  malfunction  

Manufacturer Narrative

One smiths medical cadd duodopa pump was returned for analysis.During analysis, the customer's reported problem could not be confirmed.Investigation found no issues with the pump alarming or double beeping.However, service will replace the downstream occlusion sensor as a preventive measure.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event is unknown.

Event Description

Information was received indicating that a smiths medical cadd duodopa pump exhibited alarm but the pump showed "ongoing" and seemed to be administering medicine.The reporter indicated that the cassette had been re-attached, and it had been checked that all tubes were straight, the batteries had been changed and the device had been re-started, but the alarm had not stopped.The reporter also indicated that the nurse mentioned "the patient had suddenly started to have convulsions, had been exhausted and had not reacted to anything; had been in sitting posture all the time.They had called for an ambulance and meanwhile waiting for it to arrive they had put the patient in lying position".Subsequently, the patient revived and had started answering questions.In addition, the reporter indicated that the patient had told that he felt sick, but he had no pain.After the ambulance arrived, the ambulance staff reported that the patient's blood pressure was very low, but the blood pressure values were unknown.The patient has been transferred to the hospital.No further adverse effects were reported.

Manufacturer Narrative

Additional information received that the patient blood pressure was monitored, and the patient was not hospitalized for the night.It was reported on (b)(6) 2019 that convulsions/seizures had recovered/resolved from convulsions.It was reported that the estimated the weight to be about 50-55 kg.

• Brand Name: CADD DUODOPA PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8927382
• MDR Text Key: 162036903
• Report Number: 3012307300-2019-04305
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization