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

Model Number CAR-500

Device Problems Crack (1135); Fluid/Blood Leak (1250); Defective Component (2292); Connection Problem (2900); Filtration Problem (2941); Air/Gas in Device (4062)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Lot #10778017- cvvh filter.3 filters with this lot number malfunctioned.First filter when priming circuit-- leaking from below the machine and a crack found in the filter tubing.Unable to use for patient care and large amount of water spilt.Second filter when priming circuit-- connections were not correct from the packaging and water was shooting out each side of the filter and machine causing large amount of water to spill.Unable to use filter.Third filter, pulled large amount of amount air so much so that patient was almost harmed, and filter was unable to return blood.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 16023130
• MDR Text Key: 305929805
• Report Number: 16023130
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White