MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE PUREMA; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 10978013

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

During treatment, therapy fluid was noted to be leaking from the cartridge used for nxstage continuous renal replacement therapy (crrt).After blood was returned to the patient and the cartridge removed, a puncture/tear was found in the plastic lining of the cartridge.The machine is not believed to have malfunctioned, it had been in regular use for weeks.The cartridge had been used for approximately 12 hours before the leak began.

• Brand Name: NXSTAGE CARTRIDGE PUREMA
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.
• MDR Report Key: 13808835
• MDR Text Key: 287553149
• Report Number: MW5108235
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/01/2023
• Device Lot Number: 10978013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1