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

Model Number 21-7411-51

Device Problems Product Quality Problem (1506); Application Program Problem (2880); Loss of Data (2903)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Insufficient Information (4580)

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 lost programming and received message maintenance due (b)(6) 2024 while hospitalized.The issue did not occur while in use.They were hospitalized because of shortness of breath and fluid in their lungs.Patient switched infusing on their back up pump, no break in therapy.No patient injury reported.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16552854
• MDR Text Key: 311406327
• Report Number: 3012307300-2023-02592
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7411-51
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male