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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Partial Blockage (1065); Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the tubing occluded under the flow stop arm.The pump did detect the occlusion and stopped infusing, triggering an alarm of downstream occlusion, and resulted in an under delivery of the fluid/medication, causing an interruption in therapy.The pump was inspected by the pharmacist and found to have several bubbles in and around the flow stop arm.A new cassette was prepared with the remaining amount of medication and attached back on the patient and the patient was able to complete their therapy.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.

• Brand Name: CADD CASSETTE RESERVOIRS WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16368226
• MDR Text Key: 309496422
• Report Number: 3012307300-2023-01202
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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 Expiration Date: 05/01/2023
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4279821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1