MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS - FLOW STOP; PUMP, INFUSION

Model Number 21-7302-24

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

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited "no disposable, clamp tubing" alarm and the cassette unable to be recognized.No patient injury reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One sample was received without the original packaging, in used condition, decontaminated and inside in a plastic bag.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.Visual inspection did not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the failure mode reported.The sample was received without a blue clip and without a white cap.During the functional testing, the sample was fully primed and connected without difficulty, the pump was set running and no alarm was activated.The complaint was not confirmed.The root cause could not be determined due to the complaint not being confirmed.The actions taken were not performed due complaint was not confirmed.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Type of Device: PUMP, INFUSION
• 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 12878274
• MDR Text Key: 281281863
• Report Number: 3012307300-2021-11892
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4120063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1