MAUDE Adverse Event Report: NULL CADD MS3 INFUSION CARTRIDGE; ADMINISTRATION, INTRAVASCULAR

Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Information was received indicating that a pump with cadd ms3 cartridges was alarming two to fours hours before the low cartridge alert.No additional information is available at this time.

Event Description

Information was received indicating that a pump with cadd ms3 cartridges was alarming two to fours hours before the low cartridge alert.No additional information is available at this time.

• Brand Name: CADD MS3 INFUSION CARTRIDGE
• Type of Device: ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 13472747
• MDR Text Key: 285244666
• Report Number: 3012307300-2022-02793
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1