MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NX STAGE CRRT CARTIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number CAR-500

Device Problems Product Quality Problem (1506); Material Twisted/Bent (2981); Incomplete or Inadequate Priming (4041)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Rn stated in email to writer with the pictures in the document that "cvvh high balance chamber alarms when priming due to defective filter tubing was kinked at one of the pressure sensor sites.".

• Brand Name: NX STAGE CRRT CARTIDGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 16157089
• MDR Text Key: 307280069
• Report Number: 16157089
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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
• Device Lot Number: 20678013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male