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

Device Problem Pressure Problem (3012)

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

Event Date 01/30/2021

Event Type  malfunction  

Event Description

Patient reported that cadd legacy alarming high pressure.After checking line, had patient replace tubing.Alann stopped.No further details provided.No side effects reported.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITH MEDICAL ASD, INC.
• MDR Report Key: 13426444
• MDR Text Key: 285014490
• Report Number: MW5107164
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female