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

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 had failed volume accuracy testing.There was no patient present at the time of the event.There were no reported adverse events.

Manufacturer Narrative

Other, other text: one cadd solis hpca pump was returned for analysis in good condition.The event history log revealed on evidence of the reported complaint.Delivery accuracy testing performed; inability to confirm complaint.The testing found that the pumps average delivery error was within specification.Based on the evidence, there was no fault found as the complaint was not confirmed.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10279909
• MDR Text Key: 199041537
• Report Number: 3012307300-2020-07354
• 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: 09/01/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1