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

Model Number 21-2111-0300-01

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a smiths medical pump was failing volume metric accuracy test.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history review.A product sample was received for evaluation.Visual inspection revealed there was no physical damage.During functional testing, unable to duplicate the reported problem.The device's delivery accuracy was running at three different tests, all of the tests were found to be within factory specifications for accuracy.The root could not be determined, as no faults found with the pump.However, performed preventative maintenance on pump., corrected data: h6 - corrected to 4582.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• 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; st anthony north health campus; minneapolis, MN 55442
• MDR Report Key: 12112409
• MDR Text Key: 259985246
• Report Number: 3012307300-2021-06820
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2111-0300-01
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1