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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A patient receiving continuous infusion 5-fu via a cadd pump over 46 hours experienced their cadd pump alarming the following day after their pump was started.Cadd pump alarm was described as "disposable pump won't run".The problem could not be resolved over the phone by staff or by the manufacturer (infusystems).The patient was instructed to come to infusion.A different pump was tried, but the same alarm code sounded; thus, suggesting an issue with the cassette.A new cassette was made with remaining 55.8 ml of 5-fu.Fda safety report id# (b)(4).

• Brand Name: 100 ML CADD CASSETTE PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10046535
• MDR Text Key: 190766402
• Report Number: MW5094451
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 05/08/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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 Catalogue Number: GPIN 10610586027239
• Device Lot Number: 3939036
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1