MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CARTRIDGE; SET, I.V. FLUID TRANSFER

Lot Number 10-21072

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Description

Inbound.Patient reports receiving alert for treprostinil low cartridge alarm with 1 generic cadd ms3 pump, cadd generic cartridge shows 1 ml remaining with alarm, pump serial number (b)(4) and cartridge lot number 10·21072 and expiration date 07/19/2023.Reports cartridge hard to push but no other observable differences.Pump replaced.Cartridge not on hand for return, no further details provided.

• Brand Name: CARTRIDGE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13093611
• MDR Text Key: 283092840
• Report Number: MW5106294
• Device Sequence Number: 2
• Product Code: LHI
• 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: 12/13/2021
• 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?: No
• Device Expiration Date: 07/19/2023
• Device Lot Number: 10-21072
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2021
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female