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

Model Number 1400

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 07/23/2020

Event Type  malfunction  

Event Description

Information was received indicating that a patient changed the continuous rate on a smiths medical cadd-legacy duodopa ambulatory infusion pump "occasionally if she needs to." it was reported that the continuous rate suggested by the referring unit was 2.6 ml/hr and the patient was setting it to 3.6 ml/hr.Per reporter the patient reported being "very hyper." it was reported that the patient was advised to reduce the continuous rate back to 2.6 ml/hr and education was provided to the patient "around dose changes etc and importance of compliance with pump." patient was reported as "feeling much better".

Manufacturer Narrative

Other, other text: additional information was received with patient information: updated a2, a3.

Manufacturer Narrative

Other text: additional information was received indicating the patient reported overall improvement in hyperness, is hyper if anxious or concerned over something, but mainly feels improvement.It was reported that the patient was prescribed xanax at their last outpatient review, but not able to take as it makes her drowsy.Patient reported continuous day rate on pump is 2.6ml/hr, but occasionally increases to 2.8ml/hr if "particularly active" and reports being active most days.No dyskinesia at time of review, patient denies hallucinations and feels thoughts and thought processing clear.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10436946
• MDR Text Key: 203847886
• Report Number: 3012307300-2020-08382
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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: 21-1400-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR