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

Model Number 6400

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that an occlusion alarm occurred to a smiths medical cadd-legacy® pca pump.There were no reported adverse effects.

Manufacturer Narrative

One cadd cadd-legacy 1 pump was returned for analysis in good condition.The customer's reported problem was "high pressure".Inspection of the pump's event log indicated high pressure.Evaluation testing consisted of powering on pump, attaching cassette, and visual inspection.Investigator was not able to duplicate reported problem.Sensor testing found the downstream and upstream sensors were within manufacturing specification.No problem found with pump.The device history record was reviewed and found to be in compliance.No manufacturing or testing issues were found.

• Brand Name: CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7294659
• MDR Text Key: 101012551
• Report Number: 3012307300-2018-00361
• Device Sequence Number: 1
• Product Code: MEA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6400
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1