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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 Abdominal Pain (1685); Anemia (1706); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Myocardial Infarction (1969); Nausea (1970); Rash (2033); Jaundice (2187); Chills (2191); Cramp(s) (2193); Dizziness (2194); Diaphoresis (2452)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
The cycler has not been received for evaluation. A device history record (dhr) review was conducted for the cycler which met all manufacturing requirements and specifications prior to release of the unit. There is no information to indicate that a malfunction occurred. The device met all quality criteria, manufacturing requirements and specifications prior to release. Biocompatibility has been established. The user guide warns that the patient¿s blood pressure, vital signs, general well-being, and physical status should be monitored closely throughout the treatment in order to detect potential complications early and initiate appropriate remedial measures if necessary. Udi for nx1000-1: (b)(4).
 
Event Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) regarding a (b)(6) female patient with a history of anemia, iga nephropathy & end stage renal disease (esrd), hypertension, gastroesophageal reflux disease (gerd) and paroxysmal supraventricular tachycardia (psvt), who experienced chest pain and cramping during a nocturnal home hemodialysis treatment on (b)(6) 2019. The chest pain intensified during rinseback of the extracorporeal blood circuit, after which the patient slept for approximately two hours. Chest pains remained present on awaking with shortness of breath and a jaundiced appearance. The patient was admitted to hospital on (b)(6) 2019. Additional information was received on (b)(6) 2019 from the htn revealing that symptoms on admission included nausea, chills, diaphoresis, mild upper abdominal pain, lightheadedness, fatigue, diarrhea, and a red rash involving the face and upper chest. Ekg and troponin levels revealed changes consistent with a non-st-elevation myocardial infarction (nstemi). Nuclear stress testing, coombs test, transthoracic echo, upper right quadrant abdominal ultrasound and chest xray and ct were unremarkable. The patient was given two units of packed red blood cells to achieve a hemoglobin (hb) of 7. 7g/dl on (b)(6) 2019 (hb on admission not provided). Other treatment during hospitalization included hemodialysis, intravenous nitroglycerin and heparin (nos). Symptoms resolved, and the patient was discharged with a diagnosis of nstemi and chest pain secondary to anemia on (b)(6) 2019 to continue home hemodialysis therapy.
 
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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 Key8654728
MDR Text Key146625378
Report Number3003464075-2019-00017
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 01/01/2005,05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E W/ SERVICE COMPUTER
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 Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/30/2019 Patient Sequence Number: 1
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