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

Catalog Number CAR-125-B

Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/14/2019

Event Type  malfunction  

Event Description

Pediatric nxstage machine had two critical alarms on two different pumps while priming.The first was a blood leak alarm and the second on the other pediatric machine was a therapy fluid balance cartridge leak (red alarm 90).Both times the disposable equipment was thrown out and he set up process started with a new machine.Fda safety report id# (b)(4).

• Brand Name: NXSTAGE MEDICAL PEDIATRIC MEDICAL, INC.
• Type of Device: DIALYSIS, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC. ; lawrence MA 01843
• MDR Report Key: 8735048
• MDR Text Key: 149376321
• Report Number: MW5087603
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2020
• Device Catalogue Number: CAR-125-B
• Device Lot Number: 81077018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 4