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

Device Problem Device Alarm System (1012)

Patient Problem Blood Loss (2597)

Event Date 12/08/2019

Event Type  No Answer Provided  

Event Description

Pt with continuous renal replacement therapy running, machine rang error #715 blood leak.Attempted to return blood to patient, but alarm persisted.2/3 blood returned.When machine was opened, there was drops of clear liquid on the cartridge and the machine.Machine and cartridge saved, work order placed for machine.Company called to notify of problem.

• 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: 9859545
• MDR Text Key: 184265309
• Report Number: 9859545
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1