MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMPS ? 2120; PUMP, INFUSION

Model Number 2120

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Type  malfunction  

Event Description

It was reported that the device showed cassette issues alarms "cassette not attached properly" which occurred during testing, and there was no patient involvement during the procedure.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#(b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was returned for evaluation and was found all intact with no external.The event history log (ehl) showed a high alarm displayed: cassette not attached properly and high alarm silenced: cassette not attached properly.Visual and functional testing was performed.The reported issue was able to be duplicated.The technician found the downstream occlusion sensor (dso) was inoperable.The root cause of the issue was unable to be determined.The downstream occlusion sensor (dso) was replaced.

• Brand Name: CADD SOLIS VIP PUMPS ? 2120
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16665790
• MDR Text Key: 312608897
• Report Number: 3012307300-2023-03417
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517096378
• UDI-Public: 15019517096378
• 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
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• 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: 21-2120-0103-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1