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

Model Number 2120

Device Problems Device Alarm System (1012); Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the pump screen was red with triangles and the screen indicated an error message.The patient was instructed to open and close the battery door; however, the alarm continued.The user was instructed to remove the batteries from the pump from a full minute and replace the batteries.The device continued to alarm and there was no change in the screen.Patient was instructed to remove the batteries and clamp the tubing at the nearest port.Patient was instructed to call the doctor.A returned order for the device was issued.No patient injury was reported.

Manufacturer Narrative

Most probable cause for ec 45630 is a defective motor.Product was not returned, so complaint could not be verified.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16117400
• MDR Text Key: 308175251
• Report Number: 3012307300-2023-00194
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517150001
• UDI-Public: 15019517150001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0105-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1