MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS - FLOW STOP; ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS

Model Number 21-7609-24

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the cassette, a "no disposable, clamp tubing" alarm sounded and the system became inoperative.The cassette was changed and the issue was resolved.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.Three pictures were provided for review and investigation of the reported event.The 3rd picture observed the tube arch height, it is difficult to know if it is within the specification for tube arch height inspection system.One (1) physical unit sample was returned for evaluation was received decontaminated and inside of plastic bag without the original package.Visual inspection: one unit was visually analyzed for tube arch height dimension, since this variable is directly related with the potential failure of delivery accuracy.The unit could not be measured with the vision system, because the cassette cannot be disassembled to insert it into the fixture of the vision system.Functional test: the unit sample was filled using a syringe and then was connected to the device; the unit was primed and connected without difficulty, the pump was set running and any alarm was activated.The failure was not confirmed.Based on the analysis conducted in the sample provided, the root cause was not determined.Action taken: no corrective actions were taken since the complaint was not confirmed.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Type of Device: ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17255168
• MDR Text Key: 318367795
• Report Number: 3012307300-2023-07017
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2023

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 Operator: Health Professional
• Device Model Number: 21-7609-24
• Device Catalogue Number: 21-7609-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1