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

Lot Number 4354591

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

Patient reports that yesterday (b)(6) 2023 one of their remodulin premix cassettes was signaling a high-pressure alarm on both of their pumps.Patient was able to switch to another cassette and continue infusion; no side effects or lapse in therapy reported.Patient was not sure if the cassette or tubing was the issue.Patient stated they are going to try and use the same premix cassette again with different tubing during their next change to determine which product is at fault and will update the pharmacy.Unknown if md aware.Lot number tubing unknown.Cassette lot number retrieved from dispensing system: 4354591.No additional info, details, or dates available.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when alarm occurred is unknown.Pump return tracking information is not applicable as no pump issue was reported.Photographs were not provided.Iv remodulin premix patient.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.Was interruption in therapy reported? no.Is the actual product available for investigation? yes.Did we replace product? no.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: mw5118342.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17118226
• MDR Text Key: 317175351
• Report Number: MW5118341
• 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: 05/31/2023

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 Lot Number: 4354591
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Age: 72 YR
• Patient Sex: Female