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

Model Number 6300

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd legacy pca pump failed volume accuracy test.There was no reported adverse event.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.There was no evidence of the reported problem in the event log.Three separate delivery accuracy tests were performed, and the pump was found to be under delivering to the manufacturing specifications.The root cause of the reported problem cannot be established.An expulsor assembly will be replaced.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: CADD LEGACY PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11992397
• MDR Text Key: 255973871
• Report Number: 3012307300-2021-05978
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1