• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number NX1000-3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Cardiopulmonary Arrest (1765); Myocardial Infarction (1969); Nausea (1970); Vomiting (2144); Heart Failure (2206)
Event Date 04/22/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. (b)(4).
 
Event Description
A report was received on (b)(6) 2020 from the home therapy nurse (htn) regarding a (b)(6) year old male with a medical history of type i diabetes, a pattern of vomiting in the mornings, coronary artery disease, myocardial infarction, implantable automatic cardiac defibrillator (aicd) and chronic heart failure who experienced nausea and vomiting prior to home hemodialysis treatment on (b)(6) 2020. The patient experienced further nausea followed by a syncopal episode and cardiac arrest approximately 45 minutes into hemodialysis therapy on (b)(6) 2020. Cardiopulmonary resuscitation was performed on site and the patient was transported to hospital. Additional information was received 27 apr 2020 - 07 may 2020 from the htn which revealed the aicd did not deliver a shock during the event and epinephrine was not given. The patient was oriented and alert on arrival at the hospital and was admitted for syncope. The patient's course of hospitalization included discovery, diagnosis and treatment, including amputation of a gangrenous index finger due to an unrelated dog bite (date of injury not provided). The patient was discharged from hospital in stable condition on (b)(6) 2020 with discharge diagnoses which included left index finger gangrene and syncope.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key10040137
MDR Text Key190804578
Report Number3003464075-2020-00024
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/08/2020 Patient Sequence Number: 1
-
-