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

Model Number UNKNOWN

Device Problems No Audible Alarm (1019); Loose or Intermittent Connection (1371)

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

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Crrt plug was knocked loose.Crrt alarm is very low and not audible outside of the patient room.

• Brand Name: NXSTAGE CRRT
• 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: 8217329
• MDR Text Key: 132244861
• Report Number: MW5082830
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR