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

Model Number 21-7302-24

Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)

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

Event Date 08/03/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited ?high pressure" error alarm.It was reported that the customer changed the cassette out and reconnected the patient and after about 5 minutes, the pump displayed the same error.According to the reported the patient then refused the rest of the treatment which was 70ml.No patient injury reported.

• Brand Name: CADD CASSETTE RESERVOIRS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12414123
• MDR Text Key: 269546216
• Report Number: 3012307300-2021-09096
• 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
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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