MAUDE Adverse Event Report: ST PAUL CADD-LEGACY ONE AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number 6400

Device Problem Failure to Prime (1492)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

Information was received indicating that both of the end users cadd legacy 1, mdl 6400, pumps were not able to be primed.It was reported that troubleshooting was unsuccessful.Per reporter the end user did not have another backup pump and was advised to go to the hospital.

Manufacturer Narrative

Report source: hospital.Medwatch: mw5105873.

• Brand Name: CADD-LEGACY ONE AMBULATORY INFUSION PUMP
• 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: 13450015
• MDR Text Key: 285037133
• Report Number: 3012307300-2022-02523
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: 10610586019548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1