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

Model Number 21-7609-24

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Three (3) pictures were attached for evaluation: in the picture 3, the technician observed the tube arch height, it was difficult to know if it was within the specification or not according to the procedure.One (1) physical unit sample was returned for evaluation.It was received decontaminated and inside of plastic bag without the original package.One unit was visually analyzed for tube arch height dimension, since this variable was direct related with the potential failure of delivery accuracy.The technician could not measured with the vision system, because the cassette cannot be disassembled to insert it into the fixture of the vision system.The sample was set for accuracy testing using a pump and a balance mettler toledo due date: january 2022 to look for unusual function.The sample decontaminated received pass the accuracy test (see disposable accuracy test report on attachments marked), thus the failure mode reported was not confirmed.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No corrective actions were taken since the complaint was not confirmed.

Event Description

It was reported that an under delivery of medical fluid was observed in the product during the use of it.After the reservoir volume empty the alarm sounded, 64 milliliters (ml) of medical fluid still remained in the cassette.No patient injury was reported.

• 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: 16854690
• MDR Text Key: 314397149
• Report Number: 3012307300-2023-04884
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2023

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: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/02/2023
• 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
• Patient Race: Asian