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

Model Number 6400

Device Problems Use of Device Problem (1670); Output Problem (3005)

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

Event Type  malfunction  

Event Description

Spontaneous.Pt's husband reported that one of pt's remodulin premix cassettes were not working; unable to obtain the lot number.Husband stated that the patient did use one cassette from emergency bag.Patient was able to use emergency cassette and continue the infusion.No changes in symptoms or meds since last month reported.No other information provided.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 device available for investigation? yes did we [mfr] replace device? yes did the patient have a backup device they were able to switch to? yes was the patient able to successfully continue their infusion? yes is the infusion life-sustaining? yes.Reported to (b)(6) by: patient/caregiver.

• Brand Name: LEGACY CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13358940
• MDR Text Key: 284681805
• Report Number: MW5106996
• 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: 12/09/2021

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 Model Number: 6400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Patient Sequence Number: 1
• Patient Sex: Female