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

Model Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Cough (4457)

Event Type  Injury  

Event Description

Iv remodulin; spontaneous; pt reported that one of the cassettes has holes in the pouch and wasted 3 ml of remodulin.Lot number 4334142.Additionally patient reported cold and possible pneumonia (not associated with device malfunction].Started doxycycline and tussin with codeine for cough.Md is aware.No other information provided.No additional info, details, or dates available.Return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate & volume delivered are unknown.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? -yes.Did the patient have additional cassettes they were able to switch to? yes, 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.Was the patient able to successfully continue their therapy? ¿ yes with impacted lot.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: 16504467
• MDR Text Key: 311040612
• Report Number: MW5115546
• 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: 03/03/2023

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 Model Number: UNKNOWN
• Device Lot Number: 4334142
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN, DOXYCYCLINE, TUSSIN WITH CODEINE.
• Patient Sex: Female