MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CARTRIDGE 3ML RG MEDICATION; ACCESSORIES, PUMP, INFUSION

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

Outbound; pt reports cadd ms3 pump alarms for low volume sooner than expected since starting treprostinil generic.No cartridge info available.Advised on lubricating cartridges, save package and call back for further issues.No further details provided.(b)(6).

• Brand Name: CARTRIDGE 3ML RG MEDICATION
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12728454
• MDR Text Key: 279774979
• Report Number: MW5105045
• Device Sequence Number: 1
• Product Code: MRZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/06/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR