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

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.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH 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 Key: 8654728
• MDR Text Key: 146625378
• Report Number: 3003464075-2019-00017
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• 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 Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-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 FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 97