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

Patient Problem Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Iv remodulin patient reports they have had unspecified changes in their breathing, which is why they are titrating again; onset/resolution dates/status unknown.Patient also reports they recently experienced a high pressure alarm while priming cassette.When high pressure alarm went off, patient switched to their back-up pump & alarm resolved.Patient states this happened another time as well & they ended up switching to their other pump & alarm resolved.Patient thinks it's a problem with the cassettes & not the pump; patient confirms both pumps are working fine.Patient confirms they didn't have to waste or discard any cassettes during these instances & had no interruption in therapy.Patient also confirms that each time there were no kinks in the tubing pathway.No other pharmacy troubleshooting was done as issues were resolved at this time.Author advised patient to continue to monitor for pump alarms or cassette issues & let pharmacy know.No additional info, details, or dates available.This is a continuous infusion.Set flow rate and 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.Lot number & expiration date of effected cassettes are unknown.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? unknown.Did we replace the product? no.Did the patient have a backup product they were able to switch to? yes.Was the patient able to successfully continue their infusion? yes.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18311231
• MDR Text Key: 330366293
• Report Number: MW5149117
• 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: 12/07/2023

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: 12/11/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN MDV.
• Patient Sex: Female