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

Device Problem Protective Measures Problem (3015)

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

Event Date 11/11/2019

Event Type  malfunction  

Event Description

Machine was alarming "low temp therapy fluid" was able to trouble shoot.Alarmed later " blood leak" unable to troubleshoot.Unable to give full amount of blood back.Took machine out to be serviced.

• 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: 9563664
• MDR Text Key: 174150429
• Report Number: 9563664
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1