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

Model Number 21-2111-0300-01

Device Problem Inaccurate Flow Rate (1249)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that the cadd solis hpca pump failed the flow test.There was no adverse event reported.

Manufacturer Narrative

Other, other text: additional information: a1, h6, h10: information was received on 12/17/2020 indicating that the failure did not happen in use with a patient, it occurred during routine maintenance.Device evaluation: one smiths medical cadd solis hpca pump was returned for analysis in a good condition.During analysis, all the 3 tests had a failed average accuracy delivery error which was out of the nominal allowed specifications.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 replacing the expulsor.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event is unknown.

Manufacturer Narrative

Other text: corrected data: correction information h6, h10.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10780080
• MDR Text Key: 214404285
• Report Number: 3012307300-2020-10944
• 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: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

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 Model Number: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 07/05/2022
• Supplement Dates FDA Received: 01/14/2021; 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• 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