MAUDE Adverse Event Report: ST PAUL CADD LEGACY 1 PUMP; PUMP, INFUSION

Model Number 21-6400-51

Device Problems Inaccurate Flow Rate (1249); Inaccurate Delivery (2339)

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

Event Type  malfunction  

Manufacturer Narrative

Operator of device: is unknown.Customer reported to fda is unknown.This 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.A product sample was received for evaluation.Visual and functional testing were performed.Performed three separate delivery accuracy tests,the pump was found to be within manufacturing specifications.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.Actions were taken to mitigate the reported issue: the downstream occlusion sensor was replaced.

Event Description

It was reported that the pump failed for delivery accuracy during testing.No patient injury was reported.

Event Description

No patient was involved.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A sample was received to perform an investigation.A visual inspection of the returned pump found the tamper seals all intact.A review of the pump event history log found no evidence related to the reported problem.Three accuracy tests were run, and the pump was found to be within manufacturing specifications.A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release and no problems or issues were identified.No root cause could be determined as the complaint could not be confirmed.

• Brand Name: CADD LEGACY 1 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: 16701526
• MDR Text Key: 312885503
• Report Number: 3012307300-2023-03746
• 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,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-6400-51
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1