MAUDE Adverse Event Report: CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the patient reported that the pump exhibited intermittent alarms of "upstream occlusion".No adverse effects reported.

Manufacturer Narrative

Other, other text: h3: one cadd cassette reservoir from part number 21-7302-24, lot number 3773554 was received decontaminated inside a plastic bag which was not its original packaging.The sample was visually inspected at a distance of 12 to 16 under normal conditions of illumination to detect conditions that could cause functional issues.The sample did not present any damage, scuffs, pinch marks, cracks, crazing, etc.Could cause the failure mode reported.The returned cassette was filled with water and connected to a cadd legacy plus pump to look for unusual function.The sample was 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 cassette.

• Brand Name: CADD CASSETTE RESERVOIRS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11879614
• MDR Text Key: 252710795
• Report Number: 3012307300-2021-05026
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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: No Information
• Device Expiration Date: 02/13/2024
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3773554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• 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