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

Catalog Number 21-6500-09

Device Problem Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection showed the pump was in good condition.A review of the event history log (ehl) showed no records related to the reported event were identified in the log.During the functional testing the reported issue was unable to be duplicated.The root cause of the issue was unable to be determined.Performed all functional testing.

Event Description

It was reported that the pump showed a discrepancy between the indicated value and the actually remaining value were observed.However, it was unknown whether this event is under or over delivery.No patient injury was reported.

• Brand Name: CADD LEGACY PLUS PUMPS
• 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: 16817507
• MDR Text Key: 314035534
• Report Number: 3012307300-2023-04596
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-6500-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1