MAUDE Adverse Event Report: CADD CASSETTE RESERVOIRS; PUMP, INFUSION

Model Number 21-7302-24

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

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

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited no disposable, pump won't run alarm.It was reported that the error would not clear and the therapies was interrupted; however, new compounded doses using cassettes from a different lot that were detected by their pump was used.No adverse effects reported.

Manufacturer Narrative

Thirty six cadd cassette reservoirs with part number 21-7302-24 and lot number 4096349 were received in new conditions with their original closed packages.The samples were visually inspected at a distance of 12? to 16? under normal conditions of illumination to detect samples conditions that could cause functional issues.The samples didn?t present any damage, scuffs, pinch marks, cracks, crazing, etc.That could cause the failure mode reported.The returned cassettes were filled with water and connected to a cadd legacy plus pump to look for unusual function.The samples were fully priming and connected without difficulty.The pump was set running and the alarm was not activated.The reported issue was not confirmed.There was no fault found with the returned cassettes.

• Brand Name: CADD CASSETTE RESERVOIRS
• Type of Device: PUMP, INFUSION
• MDR Report Key: 11887152
• MDR Text Key: 252724681
• Report Number: 3012307300-2021-05108
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4096349
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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