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

Model Number 21-7052-24

Device Problem Pressure Problem (3012)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Information was received indicating that this smiths medical cadd extension sets exhibited "overpressure" alarm.No patient injury reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received: two (2) samples were received from p/n 21-7052-24 l/n 4152708; the samples was returned decontaminated inside a plastic bag without its original package.Visual inspection result: no discrepancies or damage was observed in the returned samples.Functional testing: in order to reproduce the failure mode reported for the customer a cassette product was taken from production floor and filled as cassette ifu indicate, extension set were connected to the luer to perform a functional using a pump cadd legacy plus [cal.Id: 1.0386; due date: february 2022]; the pump was started and the alarm was activated, so the reported failure mode is confirmed.Functional test: sample was tested using a syringe with colored water to detect any occlusion.Results: during the test, the water did not pass-through filter.Complaint was confirmed.The cause of the reported problem was traced to the manufacturing process, root cause is excess of solvent by not following the manufacturing procedure.Personnel notification was performed on (b)(6) 2022 to notify production personnel about the failure mode reported by the customer.

• Brand Name: CADD EXTENSION SETS
• 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: 12995298
• MDR Text Key: 282192100
• Report Number: 3012307300-2021-12724
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Device Lot Number: 4152708
• 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: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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