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

Model Number 21-7106-24

Device Problems Increase in Pressure (1491); Improper Flow or Infusion (2954)

Patient Problems Anemia (1706); Fatigue (1849); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Iv treprostinil - pt was in hospital for a week.Date of admission and discharge not provided.White blood count went down, possibly side effects of other medication she is on.Pt was retaining a lot of fluid - around 10-11 pounds, in over a week.Pt is titrating now to improve symptoms of pah, tiredness.Pt has anemia and last night pt reported lump on the right leg.No lump now after wearing compression socks.Current weight: 149 lbs.Next appointment with md is within 1 week.Pt feels same as she did prior to starting pah therapy.Pt also reported that she had problem with tubing- she had high pressure alarm caused by tubing twice in the last 2 weeks.Confirmed tubing was attached in the right way (filter position the same as always) but there was problems with clamps and medication was not flowing freely.Unknown serial number.No additional info, details, or dates available.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate & 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? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? no; did we [mfr] replace the device? no; did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD SET EXT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17184795
• MDR Text Key: 317734540
• Report Number: MW5118686
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7106-24
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Female