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

Device Problem Increase in Pressure (1491)

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

Event Type  malfunction  

Event Description

Spontaneous: direct call from pt with pump/cassette complaint.Pt stated that lately when he pumps get down to around 40mls left she gets high pressure alarm.Both pumps and issue is not consistent just around when cassette is below half full.Counseled on general trouble shooting for high pressure alarm and detecting blockage.Pt already tried replacing lines several times and inspected for blockage.Pt suspects maybe the cassettes are faulty.Informed pt that just in case we will ship 2 new pumps as well as replacement cassettes.We will also involve cnss for a possible in person visit.Counseled pt that if issue presists that she has to go to the er to have iv line inspected.Pt confirmed that there has not been any therapy interruptions due to the complaint and that he pumps are infusing right now with no issues.Pumps sn (b)(6) and (b)(6).Patient did not provide lot number for cassettes.No add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? yes; did we replace the product? yes; did the pt have a backup product they were able to switch to? yes; was the pt able to successfully continue their infusion? yes.Reported to (b)(6) by pt/caregiver.Reference report: mw5119180, mw5119181, mw5119183.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17280641
• MDR Text Key: 318706261
• Report Number: MW5119182
• 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: 06/28/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female