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

Model Number 2120

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Application Program Problem (2880)

Patient Problems Insufficient Information (4580); 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 does not close well and resets itself from 138ml to 100ml volume.No patient injury reported.

Manufacturer Narrative

Other text: b3.Date of event is unknown.H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one device was received.A visual inspection found the tamper seals removed and a peeling downstream sensor seal.No evidence of the customer reported issue was found in the event history log.During the functional testing, the customer reported problem of the pump resetting itself was able to be duplicated.The problem was found to be caused by the main board battery.It was recommended to charge the pump for three days.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• 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: 16754148
• MDR Text Key: 313448644
• Report Number: 3012307300-2023-04216
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 21-2120-0102-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1