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

Model Number 6300

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

Event Description

Information was received indicating that a smiths cadd-legacy® pca pump was unable to administer a bolus.It was also noted that the pump incorrectly recoded that too many attempts were made to activate the pca button.There was no reported serious injury to the patient.

Manufacturer Narrative

Device evaluation: one smiths medical cadd-legacy pca pump was returned for analysis in used condition.The investigation was unable to confirm the reported problem, the pump passed all tests and was found to be operating properly.Based on the investigation, the complaint allegation was not confirmed.

• 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
• MDR Report Key: 8377555
• MDR Text Key: 137408894
• Report Number: 3012307300-2019-00878
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR