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

Model Number 21-6400-51

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

D5: operator of device is unknown.E4: customer reported to fda is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The battery contact was bent.The complaint was confirmed.Error history log review found high pressure, upstream occlusion, air in line detected messages in the event history log.Customer problem was duplicated "battery terminal damaged" issue during the investigation.The reported issue was found to be the battery contact was damaged.The root cause of the reported issue could not be determined.The battery contact was replaced to resolve the reported issue.

Event Description

It was reported that the battery terminal was damaged.No patient injury was reported.

• 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: 16919234
• MDR Text Key: 315090366
• Report Number: 3012307300-2023-05651
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2023

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 Model Number: 21-6400-51
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1