MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATIO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7301-24

Device Problems Device Alarm System (1012); Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2022

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).Additional information: (b)(6).

Event Description

Information was received indicating that a cadd medication cassette reservoir was exhibiting a high pressure" alarm after connecting the cassette to the pump.It was reported the end user attempted to use the cassette with a backup pump and observed the same issue.Per reporter a new cassette was mixed with veletri 50 ml resolving the issue.No adverse patient effects were reported.

Manufacturer Narrative

One device was returned for analysis in used condition without its original packaging, decontaminated with extension set attached and inside a plastic bag.The sample was received without the blue clip and without cap.Visual inspection showed no discrepancies.Functional testing involved filling the device with water and connecting it to a cadd legacy plus pump to look for unusual function.The sample fully primed, connected with no difficulty and no alarms were activated when the pump was set to running.Based on the investigation, the complaint allegation was not confirmed.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATIO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 13497179
• MDR Text Key: 285324476
• Report Number: 3012307300-2022-02993
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: 10610586027215
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 4158802
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1