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

Model Number 21-6300-51

Device Problem Defective Component (2292)

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 customers reported problem were found during the review of the service and repair records.A product sample was received for evaluation.Visual inspection showed no missing labels, screen was scratched but in good condition.During functional check, the reported complaint was duplicated.Attempted to power up the device but when batteries were inserted, the device immediately alarmed with a blank screen.Unable to perform testing according to procedure due to continuous alarm at device start-up.Root cause was found to be the circuit board; circuit board was replaced.

Event Description

It was reported that there was board issues.No patient injury reported.

• Brand Name: CADD LEGACY PCA 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: 16681654
• MDR Text Key: 312701415
• Report Number: 3012307300-2023-03557
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586019449
• UDI-Public: 10610586019449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-6300-51
• Device Catalogue Number: 21-6300-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1