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

Model Number 21-7349-24

Device Problems Decrease in Pressure (1490); Pressure Problem (3012); Audible Prompt/Feedback Problem (4020)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that the cadd administration sets were setting off the low pressure occlusion alarm.Customer performed a test using the oem manual and received an occlusion pressure of 8.5 psi while the acceptable range is 9 - 27 psi.It is unknown if patients were involved.

• Brand Name: CADD
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10715408
• MDR Text Key: 212446438
• Report Number: 3012307300-2020-10529
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517184235
• UDI-Public: 15019517184235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7349-24
• Device Catalogue Number: 21-7349-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1