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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Failure to Sense (1559); Output Problem (3005)

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

Event Date 08/05/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited cassette not detected error when there was 20ml or less of the volume left to infuse.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 review.Three cassette products were received for evaluation.Two samples were received in unused conditions with its original packaging inside in a plastic bag.One sample was received in used condition without its original packaging, without slide clamp and decontaminated and inside in a plastic bag.Pump tube height testing was performed.The samples were tested to measure the height of the pump tube arch and determine if are under or out of specification and the pump tube height was under specification.However, during accuracy testing, the samples received were connected to a pump and balance mettler to look for unusual function.The samples were fully priming and connected without difficultly, the pump was set running and the alarm was not activated.The samples passed the test.Lastly during functional testing, samples were filled with 100 milliters of water.The samples were connected to the pump to look for unusual function.The samples were fully priming and connected without difficultly, the pump was set running and no alarms were activated.Complaint is not confirmed.No root caused could not be determined, the complaint was not confirmed.No actions taken.

• Brand Name: CADD CASSETTE RESERVOIRS
• 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: 12420999
• MDR Text Key: 269758348
• Report Number: 3012307300-2021-09123
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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: 4092491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White