MAUDE Adverse Event Report: ST PAUL CADD LEGACY PLUS PUMPS - 6500; PUMP, INFUSION

Catalog Number 21-6500-09

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56, when additional reportable information becomes available.

Event Description

It was reported, the device during the use of the pump, a "high pressure" alarm went off.No patient injury reported.No additional information is available for this complaint.

Manufacturer Narrative

The event history log was reviewed as a result of checking the log, it confirmed that there was a record of the high-pressure alarm occurred continuously after priming or during operate on february 16, 2023.Functional test performed and it could not confirm the reported issue.The occlusion detection level of the dso sensor was within the standard.Possible defective downstream sensor or cassette product.Product is beyond a year from manufacture date and there was no indication or evidence provided in the complaint of a manufacturing defect, so a dhr review was not performed.Service history review identified the device was in for service on (06/2022) for (high pressure) and there was no indication or evidence in the service history to indicate that the complaint is related to the previous service event.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16809256
• MDR Text Key: 313948222
• Report Number: 3012307300-2023-04508
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-6500-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1