MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PCA PUMP; PUMP, INFUSION, PCA

Model Number	6300
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection found cracked housing.Functional testing noted a faulty downstream occlusion (dso) sensor.The dso sensor was replaced.The device then passed all functional tests.The service history review had no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the device was sent in for preventative maintenance, the device was no longer functioning.No additional information was provided.The device evaluation stated the downstream occlusion sensor was faulty.

• Brand Name: CADD LEGACY PCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21183571
• Report Number: 3012307300-2025-00864
• Device Sequence Number: 8546087
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: (01)10610586019357(11)180522
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown