MAUDE Adverse Event Report: ST PAUL CADD

Model Number 21-2111-0100-51

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical pump failed volume accuracy testing.There was no patient present at the time of the event.There were no reported adverse events.

Manufacturer Narrative

Other text: additional information: h6, h10.Device evaluation: one smiths medical cadd solis hpca pump was returned for analysis in a good condition.During analysis, the customer's concern regarding failed accuracy was unable to be confirmed.Delivery accuracy testing found the pump's average delivery error to be within the published specification of +/-6%.Service recommended an expulsor to be trimmed down to bring the delivery accuracy closer to nominal of a range.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10280324
• MDR Text Key: 199040216
• Report Number: 3012307300-2020-07361
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-2111-0100-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1