MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7301-24

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

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited "no cassette" alarm.It was reported that the customer switched to another pump.No patient injury reported.

Manufacturer Narrative

Five cadd cassette reservoir were returned for the evaluation of the reported issue.Samples were received in used conditions without its original packaging, decontaminated and inside in a plastic bag.There is not non-conformance or deviation related to the failure reported in the device history record for finish good and component associated.A visual inspection was performed where the samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination to detect sample conditions that could cause functional issues.The samples received doesn?t present any damaged, kink, cut or condition that could cause failure mode.A pump tube height test was then performed, and the pump tube height failed; however the samples were received in used conditions it is possible that the pump tube height was modify during the use.Sample also passed the accuracy test and functional testing.Complaint was not confirmed.No root cause was determined due complaint was not confirmed.Actions taken were not performed due complaint not being confirmed.

• Brand Name: CADD CASSETTE RESERVOIRS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12803405
• MDR Text Key: 280761383
• Report Number: 3012307300-2021-11117
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 4122830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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: 50 YR
• Patient Sex: Female