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); Hyperthermia (1909); Tachycardia (2095)

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.D5- operator of device is unknown.Lot/serial number not provided.

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 text: no product was returned.The investigation determined the most probable cause to be the expulsor, 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.

• 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: 16142813
• MDR Text Key: 308353249
• Report Number: 3012307300-2023-00394
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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