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

Model Number NX1000-16-A

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.A review of the complaint database revealed no other events of this nature for the reported device serial number.There was no indication of a device malfunction from the available information.Udi: (b)(4).

Event Description

A report was received on 04 jun 2020 from the caregiver of a (b)(6) year old female patient with multiple comorbidities including end stage renal disease with hemodialysis treatments performed using a central venous catheter, stating the patient visualized air in her blood lines (amount not available) followed by chest discomfort (nos) and shortness of breath at an unspecified time shortly after returning her blood to complete a standard home hemodialysis session on (b)(6) 2020.Additional information was received on 16 jun 2020 from the home therapy nurse (htn) indicating that the patient's symptoms improved at home within an hour and without medical intervention on (b)(6) 2020.The patient elected to go to the emergency department for assessment and was admitted for observation, serial troponins and diagnostic imaging.All testing returned unremarkable results.The attending physician indicated the event was not clinically significant and the patient was discharged without sequelae the following day, (b)(6) 2020.Per the htn, the patient continues to perform hemodialysis treatments with the nxstage system one.

• 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: 10191781
• MDR Text Key: 197808075
• Report Number: 3003464075-2020-00033
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD, NO NIBP MODULE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Weight: 89