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

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.

• 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: 10040137
• MDR Text Key: 190804578
• Report Number: 3003464075-2020-00024
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 01/01/2005,05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC 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 FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 62