MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMPS - 6500; PUMP, INFUSION

Model Number 6500

Device Problems No Audible Alarm (1019); Increased Pump Speed (1501); Inaccurate Delivery (2339)

Patient Problems Headache (1880); Tachycardia (2095); Burning Sensation (2146)

Event Date 12/27/2022

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.No product information has been provided to date.Operator of device is unknown.

Event Description

It was reported that the pump delivered inaccurate amount of medication (overdose) resulting in symptoms such as headache, feeling of heat, tachycardia at 110 without pump alarm.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: h6.Health impact, and evaluation codes: updated.No device has been returned, and no photos were provided for investigation.No event history/error log provided by the customer.The most probable cause of an over-delivery is the expulsor.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the device is returned the manufacturer will re-open the complaint for device evaluation.

• Brand Name: CADD LEGACY PLUS PUMPS - 6500
• 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; 10, avenue aristide briand; minneapolis, MN 55442
• MDR Report Key: 16143148
• MDR Text Key: 308555619
• Report Number: 3012307300-2023-00391
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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 Model Number: 6500
• Device Catalogue Number: 21-6500-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female