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

Lot Number 20678013

Device Problem Priming Problem (4040)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

Continuous veno-venous hemofiltration (cvvh_ filter wouldn't prime past minute 11.Continued to alarm and all interventions could not reconcile the alarms.Same issues with same lot number occurred this weekend but unknown if it was on the same patient.

• Brand Name: NXSTAGE CVVH FILTER
• 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: 16435435
• MDR Text Key: 310159766
• Report Number: 16435435
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20678013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Sex: Male