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

Model Number 2120

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.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 cassette was not locked to the pump.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other text: a sample was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that the tamper seal was not removed or broken.Performed functional check.Performed nda-testing of pump.The reported problem "cassette not locked" was verified.During testing found latched lock flex sensor was intermittent.Replaced latched lock flex sensor.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 was previously repaired on (b)(6) 2022.An improperly replaced dso seal could cause issues with the function of the dso sensor, but there was no indication from the evaluation that the previous repair caused the issue.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• 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; ma biomed facility; minneapolis, MN 55442
• MDR Report Key: 16077795
• MDR Text Key: 308368928
• Report Number: 3012307300-2022-28316
• 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
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0105-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1