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U.S. Department of Health and Human Services

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

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NXSTAGE MEDICAL, INC. NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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).
 
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Brand NameNXSTAGE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
MDR Report Key10307373
MDR Text Key199989846
Report NumberMW5095638
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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 Received07/21/2020
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

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