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

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Malaise (2359); Pallor (2468)

Event Type  Injury  

Event Description

Per spontaneous communication from rn (b)(6) at md office: "pt had another cadd legacy tubing leakage yesterday for most of the day.She is on iv remodulin at 150ng/kg/min and "just didn't feel right all day".Pt was pale, clammy, and lightheaded.Pt went to pulmonary rehab and was unable to finish routine.Pt initially thought it was increase in adempas dosage that made her feel this way.About 20:00pm last night, she realized her stash band was wet and remodulin had leaked onto her shirt tubing was leaking at the round white filter & she hadn't been receiving med all day.This has happened multiple times to this pt and i had another pt report the same issue yesterday in clinic (accredo pt).Because this is an ongoing problem it really must be addressed as one has to wonder about the sterility of remodulin infusing through an open to air tubing leading straight to pt's bloodstream.Is there any other tubing that could be used? i believe the mfr needs to recall all these tubings and exchange them for tubing without defects.Pt didn't want to reduce remodulin dose when restarting pump.Said she "brought" it out but my concern is the effects this has on her "right now".This is a big dose of med to be without for so many hours.Then a big bolus of med when she resumed infusion.Pt had severe nausea, vomiting and headache throughout the night despite premedicating with antiemetics, analgesics, etc.I will attempt to get lot number for you so you can f/u.Please ship new tubings to pt because i am sure tubing she has remaining are of same lot numbers.Defective tubing lot number unk.No add'l info, details or dates known.Reported to (b)(6) by health professional.Did the reported product fault occur while in use with the pt? yes; did product issue cause / contribute to pt or clinical injury? yes; was any medical intervention provided? yes; is actual product available for investigation? unk.Did pharmacy replace the product? yes; did pt have backup product they were able to switch to? yes; was pt able to successfully continue therapy? yes; is therapy life sustaining? yes; what is outcome of the event? resolved.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17781610
• MDR Text Key: 323927767
• Report Number: MW5145914
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ADEMPAS; REMODULIN
• Patient Sex: Female