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

Model Number 6400

Device Problem Device Alarm System (1012)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported by the pharmacist that a high pressure alarm occurred while using the pump.The patient was hospitalized in the emergency room but there was no information to determine if the patient was hospitalized as a result of interruption of therapy due to the pump alarming, or if they were already in the hospital before the pump alarm occurred.The alarm could not be resolved and both pumps were alarming high pressure.The tubing was attached correctly, and all clamps were open.New cassette was mixed and no visible obstructions to tubing or cassette were observed.Per the registered pharmacist notes, the patient reported to the emergency room for chest pain and shortness of breath.The devices were replaced.

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.Lot # is unknown.No information has been provided to date.

Manufacturer Narrative

Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The most probable cause is the down-stream occlusion (dso) sensor.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.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.

Manufacturer Narrative

Additional information provided: b.7., corrected data: corrected data: a.2.

• Brand Name: CADD LEGACY 1 AMBULATORY INFUSION SYSTEM
• 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: 16015256
• MDR Text Key: 305812706
• Report Number: 3012307300-2022-27980
• Device Sequence Number: 1
• Product Code: FRN
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female