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

Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); No Code Available (3191)

Event Type  No Answer Provided  

Event Description

Covid 19 related- lack of nxstage/other dialysate solutions has led our institution to use products we have not used in the past. One such product is nx stage dialysate fluids with lactate 5 liter bags. Item was ordered/used in the following situation: patient has liver failure, was found to have a rising lactate and abdominal pain with concern for possible ischemic bowel. Received ct scan to assess which was benign. Found to have been receiving dialysate containing lactate through night. Patient received unnecessary scan. Medication administered to or used by the patient: yes. (b)(6).

• Brand Name: NXSTAGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.
• MDR Report Key: 10307373
• MDR Text Key: 199989846
• Report Number: MW5095638
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage