MAUDE Adverse Event Report: ST PAUL CADD MS3 AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 21-7411-51

Device Problems Inaccurate Delivery (2339); Date/Time-Related Software Problem (2582); Improper Flow or Infusion (2954)

Patient Problems Nausea (1970); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

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 was not working properly.It was not giving them any alerts, remaining volume had been wrong, and am/pm timing was off.The patient noticed one night that cartridge was empty, but pump never alerted them, and pump stated there was still volume remaining.Patient changed the cartridge because they have been on therapy for a long time and knew it was about time to change, however they did not know how long the cartridge was empty.The pump never alerted them, and pump stated there was still volume remaining.Patient reports feeling queasy the next day but didn't think it was related to the pump issue from the night before.

Manufacturer Narrative

Additional information was received that the outcome of the event was resolved.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be the cartridge sensor not operating as intended, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.G2 email is: (b)(4).

• Brand Name: CADD MS3 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; minneapolis, MN 55442
• MDR Report Key: 16533124
• MDR Text Key: 311325346
• Report Number: 3012307300-2023-02329
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: 10610586029554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7411-51
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female