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

Model Number 21-7302-24

Device Problems Inaccurate Delivery (2339); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Patient on outpatient infusion using cadd-legacy plus infusion pump (21-6500-51) with reservoir, cassette 100ml (product id# 21-7302-24, lot#4096352) from smiths medical.Pump fails to give entire dose of fluorouracil.Error message, "no disposable, will not run" displays on the pump screen.Patient returned to clinic with 18 ml remaining of this dose out of total volume 85ml.Reached out to pump vendor who states the issue is with the reservoir, cassette.Error message occurred with other patients at this hospital.Fda safety report id # (b)(4).

• Brand Name: RESERVOIR, CASSETTE 100ML
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; hines
• MDR Report Key: 12107430
• MDR Text Key: 260071529
• Report Number: MW5102249
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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 Age: 71 YR
• Patient Weight: 100