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

Model Number 6400

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem Syncope/Fainting (4411)

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

Event Description

It was reported that the pump started beeping to change out the cassette, but according to the patient there was at least 11 hours left in the cassette as they change it 7:30 every morning.The reporter believes that this is a pump related issue and not a cassette.The patients husband mentioned that he found his wife passed out on the floor, but does not believe it was for a significant amount of time.Unknown if it was related to the pump, but claims that the patient was doing fine at the moment.The patient had since transitioned to a backup pump and is doing fine.

Manufacturer Narrative

Other text: b3: date of event and e1: contact name is unknown; no information has been provided to date.D10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received with no noted damage.The event history log found no disposable and high-pressure alarm messages after starting however the complaint was not duplicated during the functional testing.Performed three accuracy tests, and the pump was found to be within manufacturing specifications.The root cause was defective occlusion sensors however it was unknown what caused the defect.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.Replaced downstream sensor and upstream sensor with install software.The device passed all functional and delivery tests.

• Brand Name: CADD-LEGACY 1 PUMP
• 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: 16147187
• MDR Text Key: 308260921
• Report Number: 3012307300-2023-00406
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female