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

Catalog Number 21-2111-0100-51

Device Problems Inaccurate Delivery (2339); 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 the accuracy test current during annual preventative maintenance and no adverse effect involving a patient as this device was removed from service upon failing accuracy test.

Manufacturer Narrative

Other text: device evaluation: one device was returned for analysis in used condition.Visual inspection showed the tamper seal had been removed, the lcd lens was scratched, pump was dirty, upstream sensor seal was worn and the downstream sensor seal was peeling.Functional testing was able to duplicate the reported issue.The investigation determined that an issue with the expulsor was the cause of the reported issue.The expulsor was replaced to bring the delivery into a more nominal range.As the device is beyond a year from manufacture and with no indication of a manufacturing defect found during evaluation, no device history review was performed.Per service history review this device has not been in for service previously.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; st anthony north health campus; minneapolis, MN 55442
• MDR Report Key: 16487198
• MDR Text Key: 310787928
• Report Number: 3012307300-2023-02027
• Device Sequence Number: 1
• Product Code: MEA
• 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: 08/11/2023

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 Catalogue Number: 21-2111-0100-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/06/2023
• 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: 07/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1