MAUDE Adverse Event Report: WHELE LLC / CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD. CARTRIDGE 3ML RG MEDICATION; ACCESSORIES, PUMP, INFUSION

Lot Number 10-210720

Device Problems Device Alarm System (1012); Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Inbound; pt reports treprostinil ms3 pump alarming low volume when medication remains in cartridge.Pump alarms low volume at 48 hrs instead of usual 72 hrs.Alarms with generic cadd ms3 3 ml cartridge.Rg3 cartridge syringe lot number 10-210408, exp "20260407" and rg3 cartridge syringe lot number 10-210720, exp 07/19/2023.No further details provided.

• Brand Name: CARTRIDGE 3ML RG MEDICATION
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): WHELE LLC / CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
• MDR Report Key: 13282881
• MDR Text Key: 284107665
• Report Number: MW5106699
• Device Sequence Number: 2
• Product Code: MRZ
• 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: 01/05/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 10-210720
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Age: 50 YR
• Patient Sex: Female