MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PUMP; PUMP, INFUSION

Model Number 21-6500-51

Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

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 5.1ml remaining of this dose.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: PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12099350
• MDR Text Key: 260072467
• Report Number: MW5102222
• Device Sequence Number: 2
• Product Code: FRN
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-6500-51
• 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: 79 YR
• Patient Weight: 76