MAUDE Adverse Event Report: ST PAUL CADD SOLIS VIP PUMPS; PUMP, INFUSION

Model Number 21-2111-0401-51

Device Problems Inaccurate Flow Rate (1249); Volume Accuracy Problem (1675); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Manufacturer Narrative

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 the pump failed volume test.No patient involvement reported.

Manufacturer Narrative

One infusion pump was received for evaluation.Visual inspection found tamper seal broken, and scratched lens.No evidence in the event history log for the reported issue.Running three accuracy tests, the pump was found to be over delivering to the manufacturing specifications.The reported problem was duplicated.The cause of the reported problem is the expulsor is damaged.The expulsor was replaced.With no indication of a manufacturing defect found during evaluation, no device history review was performed.A review of service history found the device had not previously been in for service.

• Brand Name: CADD SOLIS VIP PUMPS
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16586787
• MDR Text Key: 311745027
• Report Number: 3012307300-2023-02828
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: 15019517099690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2111-0401-51
• Device Catalogue Number: 21-2111-0401-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1