MAUDE Adverse Event Report: NULL CADD LEGACY PLUS PUMPS 6500; PUMP, INFUSION

Catalog Number 21-6500-09

Device Problem Device Alarm System (1012)

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

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.

Event Description

It was reported during use the pump alarmed "high pressure".No patient injury.

Manufacturer Narrative

Other text: the event history log was reviewed and as a result of checking the log, it confirmed that there was a record of the high-pressure alarm occurred continuously after power on or during operate on april 2, 2023.It could not confirm the reported issue.The occlusion detection level of the dso sensor was within the standard.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device has not been in for service in the previous 12 months (serviced on 11/2021) and there was no indication the complaint was related to previous service of the device.

• Brand Name: CADD LEGACY PLUS PUMPS 6500
• Type of Device: PUMP, INFUSION
• Manufacturer (Section G): NULL
• MDR Report Key: 16837334
• MDR Text Key: 314389214
• Report Number: 3012307300-2023-04758
• 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

• 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
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1