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

Model Number 21-2111-0402-51L

Device Problems Device Alarm System (1012); Partial Blockage (1065); Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported, the pump alarmed continuous downstream occlusion alarm.The downstream pressure test done.And found the occlusion alarm activated at 4-5 psi range, which is outside tolerance.No adverse patient effects were reported by the customer.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.

Manufacturer Narrative

Device evaluation: one device was received.A visual inspection found the tamper seal removed and a bubbled dso seal.A review of the event history log found multiple downstream occlusion alarm messages.During the functional testing, the customer reported issue was confirmed when the device failed the dso trip point test.The faulty dso sensor was found to be the cause of the reported issue.The dso sensor was replaced.Product is beyond one 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 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17199434
• MDR Text Key: 317943895
• Report Number: 3012307300-2023-06624
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517154986
• UDI-Public: 15019517154986
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2111-0402-51L
• Device Catalogue Number: 21-2111-0402-51L
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1