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

Lot Number 4329619

Device Problems Fluid/Blood Leak (1250); Defective Component (2292); Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Event Description

Patient reports they made a cassette and when checking for air bubbles, the cassette tipped over and some of the remodulin solution flowed out.Patient stated they believe the bag inside the cassette failed.Patient confirmed they made a new cassette and used that new cassette to successfully continue their iv infusion.Lat number of defective cassette: (b)(4).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 and volume delivered are unknown.No pump alarm sounded; position of the pump at time of event unk.Did the reported product fault occur while in use with the pt? no.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual cassette available for investigation? yes.Did we [mfr] replace the cassette? no.Did the pt have add'l cassettes they were able to switch to? yes.If yes, was the pt able to successfully continue their infusion? na.Is the infusion life sustaining? yes.What is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16427485
• MDR Text Key: 310147620
• Report Number: MW5115105
• 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: 02/17/2023

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: 4329619
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2023
• Patient Sequence Number: 1
• Patient Sex: Female