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

Model Number 6400

Device Problems Device Alarm System (1012); Failure to Infuse (2340)

Patient Problem Syncope/Fainting (4411)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.No product sample was received.Visual and functional testing was performed.The device was found in-tact, and the event history log (ehl) showed a high-pressure alarm message after pump starting.Performed pump's pressure switch test and the test results were found to be activated high out of the pump's manufacturing specifications.The investigation was unable to repeat or confirm the customer?s reported issue.It was recommended that the downstream occlusion sensor be replaced.The root cause of the reported issue was undetermined.

Event Description

Per medwatch: it was reported that the patient called to state that the pump failed due to high pressure alarm.The patient was unable to get it working again.She tried to switch to her back up pump while calling us.However, she stated she passed out and her sister called the emergency medical technician) (emt).The patient stated it was around 15 minutes from pump failure to when the backup pump was able to restart.The patient later reported that the back up pump was infusing correctly/successfully.Also received a call from the hospital, stating the patient has been admitted due to (unspecified) "changes in the patient's lab values".No further information has been provided.

• Brand Name: CADD LEGACY ONE AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16611960
• MDR Text Key: 311958933
• Report Number: 3012307300-2023-03016
• 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
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2004
• 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: 47 YR
• Patient Sex: Female