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

Lot Number 4365511

Device Problem Gas/Air Leak (2946)

Patient Problem Weight Changes (2607)

Event Type  Injury  

Event Description

Patient reports weight increase from 146lbs.To 151.2 lbs.(5.2lb.Weight gain) over past week; patient stated increase in their abdomen, not their legs.Author advised that weight gain needs to be reported to the md office.Patient reports they were taking torsemide every other day, but md told them to increase to daily if needed.Patient reports they have to be careful due to kidneys with diuretic.Patient stated they would text their registered nurse at md office to notify.Author will also contact md office to notify.Patient also reports a product complaint about cassettes lot number 4365511, expiration date 01/18/22.Patient reports having issues getting all the bubbles out when filling the cassettes, very difficult, stated most of the cassettes they got with this past shipment has that issue; exact number of cassettes affected is unknown.Patient reports they are still using the cassettes as they are functional.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 not applicable as no pump alarm was reported.Pump a return tracking information is not applicable as no pump issue was reported.Photographs were not provided.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? n/a.Is the actual cassette available for investigation? yes.Did we replace the cassette/device/product? no, pt still able to use.Did the patient have additional cassettes they were able to switch to? not needed.If yes, was the patient able to successfully continue their infusion? yes.If no, what was the patient instructed to do in able to continue their infusion? n/a.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Resolved? yes.Ongoing? no.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: 17031594
• MDR Text Key: 316319188
• Report Number: MW5117990
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 05/22/2023

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
• Device Lot Number: 4365511
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2023
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL.
• Patient Sex: Female