MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE RESERVOIR 100ML; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problems Device Sensing Problem (2917); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

Patient sent home with fluorouracil infusion as part of his chemo regimen.Fluorouracil infused via smiths medical cadd legacy pump using a 100ml cadd cassette reservoir with flow stop (ref 21-7302-24).Midway through the infusion, pump error occurred at patient's home: "no disposable attached." we understand this error to mean the pump does not sense the cassette.This same scenario has now occurred six times in the past two months.The patients infusions are interrupted/delayed, with the patient needing to return to the hospital and wait while a new cassette is compounded by pharmacy staff.Discussions with the company smiths-medical have yielded mixed results - one representative noted this was potentially a known issue, while others have refuted that claim.A recent discussion with an area pharmacist confirmed that other (b)(6)facilities are dealing with this same issue, and have had similar responses from smiths-medical.Fda safety report id# (b)(4).

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR 100ML
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; minneapolis MN 55350
• MDR Report Key: 12129952
• MDR Text Key: 260463417
• Report Number: MW5102310
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/01/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Lot Number: 4096352
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 103