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U.S. Department of Health and Human Services

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

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anoxia (1711); Cardiopulmonary Arrest (1765); Cyanosis (1798); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Loss of consciousness (2418); Loss Of Pulse (2562)
Event Date 10/26/2020
Event Type  Death  
Manufacturer Narrative
The involved cycler has not been received for evaluation. 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. Based on the available information, there is no evidence to indicate that a malfunction occurred. A search of the complaint database revealed no other serious events associated with this device. Udi #: (b)(4).
 
Event Description
A report was received on 26 oct 2020 from the home therapy nurse (htn) of a (b)(6) year old female with significant comorbidities including end stage renal disease, stating the patient experienced an adverse event (nos) during their first in-center hemodialysis treatment with the nxstage system on (b)(6) 2020. Additional information was received on 02-13 nov 2020 from the htn stating the patient became symptomatic within minutes of initiating treatment. Symptoms included shortness of breath, hypertension, cyanosis, abnormal respirations, and unresponsiveness. Nasal oxygen was applied and emergency medical services were summoned. During transport to hospital, the patient became pulseless and cardiopulmonary resuscitation (cpr) measures were initiated. The patient received bag valve mask oxygenation and was in pulseless electrical activity upon arrival to the emergency room (er) where they were intubated. Cpr continued and included 9 doses of epinephrine, 1 amp of calcium, 1 gram of magnesium, and defibrillation x3. Following return of circulation, the patient received 1 amp of bicarb and 125 mg of solu-medrol. The patient was admitted to the intensive care unit on mechanical ventilation and was diagnosed with cardiopulmonary arrest and anoxic brain injury. The patient was extubated, transitioned into comfort care, and expired on (b)(6) 2020.
 
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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 Key10891371
MDR Text Key217921062
Report Number3003464075-2020-00076
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/24/2020 Patient Sequence Number: 1
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