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

Model Number 21-7302-24

Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675)

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

Event Date 03/21/2021

Event Type  malfunction  

Event Description

Information was received indicating that during bench testing of this smiths medical cadd cassette reservoirs, overdelivering at inconsistent rates was noticed.It was reported that when testing solis pump using the cadd cassettes with 20 ml of pca dose and checking the delivery percentage the cassettes, were overdelivering 2ml plus over our limit.No patient injury reported.

Manufacturer Narrative

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 record review.The returned samples were received inside a plastic bag, in decontaminated condition without its original packaging.Visual and functional testing were performed.The sample was visually inspected at 12 to 16 inches under normal conditions of illumination according to procedure.Visual inspection did not present any damage, scuffs, pinch marks, cracks, crazing, etc.That could cause the failure mode reported.During the functional testing of the twenty-four (24) samples received only one (1) was tested to confirm the failure mode reported.The sample was fully primed and connected without difficulty, the pump was set running and the alarm was not activated, however delivery accuracy test results were out of specifications.The complaint was confirmed.The root cause cannot be determined.A corrective and preventative action has been opened to address the reported issue.

• Brand Name: CADD CASSETTE RESERVOIRS - 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; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11721623
• MDR Text Key: 247209042
• Report Number: 3012307300-2021-03434
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4084909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• 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