MAUDE Adverse Event Report: ST PAUL CADD LEGACY 1 PUMPS - 6400; PUMP, INFUSION

Model Number 21-6400-51

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Type  malfunction  

Event Description

It was reported that the device will not start (at testing/date unknown).There were no reports of patient harm.

Manufacturer Narrative

This remediation 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 returned for evaluation and was found all intact with no external.The event history log (ehl) showed 1660 and high pressure messages.Visual and functional testing was performed.The reported issue was able to be duplicated.The pump was found to be displaying "1660" error code alarm message on power up when batteries are inserted during the investigation.Multiple high pressure after pump starting with an error code 1660 alarm messages were found in the pump's event history logs.The investigation found fluid ingression on pump by the chassis base of the downstream occlusion sensor.The microprocessor unit board and downstream occlusion sensor were replaced.The root cause of the issue was unable to be determined.

• Brand Name: CADD LEGACY 1 PUMPS - 6400
• 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: 16643363
• MDR Text Key: 312320133
• Report Number: 3012307300-2023-03258
• 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
• Report Date: 03/30/2023

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: Health Professional
• 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: 07/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1