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

Lot Number 91178002.

Device Problems Gas/Air Leak (2946); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2020

Event Type  malfunction  

Event Description

Car 500 crrt filter saline t on the access line was sucking air.This did not appear to be an issue during prime but soon after patient was connected to machine.Unable to return the blood to patient.

• Brand Name: NXSTAGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 10232591
• MDR Text Key: 197592461
• Report Number: 10232591
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 91178002.
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA