MAUDE Adverse Event Report: ST PAUL CADD LEGACY 1 PUMPS; PUMP, INFUSION

Model Number 6400

Device Problems Product Quality Problem (1506); Defective Device (2588)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Report source is unknown.

Event Description

It was reported that the pump stopped working in the middle of the night.Patient also reports red and itchy site.No medical or surgical intervention was reported.

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause is a loss of power, batteries, or power connection; however, this cannot be confirmed as no product was returned for investigation.The product is beyond a year from manufacture date and there was no indication or evidence provided in the complaint of a manufacturing defect, so a dhr review was not performed.A service history review identified this device has not been in for service in the previous year and there was no indication or evidence provided in the complaint of a service issue.

• Brand Name: CADD LEGACY 1 PUMPS
• 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: 15739069
• MDR Text Key: 307195343
• Report Number: 3012307300-2022-26808
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 127 KG