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

Device Problem Insufficient Information (3190)

Patient Problem Abdominal Cramps (2543)

Event Type  Injury  

Event Description

Iv epoprostenol sdv g-veletri pt- spoke with patient's husband.Patient was admitted yesterday morning for a stomach ileus issue and does not have an expected discharge date yet.Confirmed veletri therapy has not been interrupted and that dose remains the same.He also mentioned an issue with patient's tubing last week.Details not provided regarding what the issue with the tubing was.However, patient was able to resolve.Unknown what patient did to resolve issue.Unknown lot number/expiration date of tubing.She was off the medication for 14 minutes due to this.No reported issues since this.No add'l info, details, or dates available, ext set return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of the pump when tubing issue occurred is unk.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual product available for investigation? unk.Did we [mfr] replace the product? no, not needed; did the pt have a backup product they were able to switch to? yes.Was the pt able to successfully continue their therapy? 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: 16305220
• MDR Text Key: 309259969
• Report Number: MW5114696
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Patient Sequence Number: 1
• Treatment: OPSUMIT; VELETRI
• Patient Outcome(s): Hospitalization
• Patient Sex: Female