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

Catalog Number 21-7302-24

Device Problems Failure to Deliver (2338); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

Cadd pump will cease to administer medication after several hours, error message of "no disposable pump won't run".Noticed that issue was mainly affecting a specific lot of cadd pump cassette.Fda safety report id # (b)(4).

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN 55442
• MDR Report Key: 11929568
• MDR Text Key: 254375743
• Report Number: MW5101663
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4096349
• Was Device Available for Evaluation?: Yes
• 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