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

Model Number 6500

Device Problems Device Alarm System (1012); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: udi and g5 are unknown.

Event Description

It was reported that the patient experienced issues with the cassette.The pump would beep, and the patient had to change out the cassette as the therapy did not resume.It was unknown if there were any adverse patient effects.

• Brand Name: CADD-LEGACY PLUS 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: 18164590
• MDR Text Key: 328512025
• Report Number: 3012307300-2023-10622
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female