MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER

Model Number UNKNOWN

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

Iv remodulin.Spontaneous call from patient.Patient calling in reporting that she had a cassette issue while mixing and had to waste the full cassette.Patient mixed another cassette but is now completely out of medication.Current cassette will last until more med is sent to patient.Patient stated one pump was not working for her as well.Patient unsure of exact malfunction.Serial number not obtained during call due to it being the middle of the night.No other information available.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 patient? ¿ no.Did the product issue cause or contribute to patient or clinical injury? ¿ no.If yes, was any medical intervention provided? - no.Is the actual product available for investigation? - yes.Did we replace product? ¿ yes.Did the patient have a backup product they were able to switch to? -yes.Was the patient able to successfully continue their therapy? - yes.Reported to (b)(6) by: patient/caregiver.Reference report: mw5117226.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16868073
• MDR Text Key: 314582158
• Report Number: MW5117225
• Device Sequence Number: 1
• Product Code: LHI
• 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: 04/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Patient Sequence Number: 1
• Patient Sex: Female