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

Model Number 21-7106-24

Patient Problem Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Spoke with patient.Patient reported high pressure alarm a few days ago.Same lot of cadd ext set again: 4365467.She said she replaced the tubing and everything was running fine.She has only had problems with that particular lot.She said she threw away whatever other tubing's she had for that lot as well.Side effects reported: congestion, md aware, used afrin, off for 2 weeks, has rebound congestion.Md also has had patient use: sudafed, claritin, and steroid nasal spray patient says she feels they do not help, only the afrin does.Worse at rest advised if gets worse or intolerable to let us know so we can notify md.Patient voiced understanding.No other information provided, details, or dates available.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or continue pt or clinical injury? no; was interruption in therapy reported? no; is the actual product available for investigation? no; pt said "she threw all the lots with the same #"; did we replace the product? yes; did the pt have a backup product they were able to switch to?yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17643072
• MDR Text Key: 322278834
• Report Number: MW5145031
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7106-24
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL 48NG/KG/MIN
• Patient Sex: Female