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

Model Number NX1000-3

Device Problem Insufficient Information (3190)

Patient Problems Malaise (2359); Chest Tightness/Pressure (2463); Blood Loss (2597)

Event Date 10/01/2020

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.The nxstage system one user guide warns that a trained and qualified person must observe all treatments so that alarms and harmful conditions can be responded to promptly.There is no information to indicate that a malfunction occurred.(b)(4).

Event Description

A report was received on 02 oct 2020 from a (b)(6) year old male patient with end stage renal disease who had recently felt unwell (nos) and who stated he observed a "large pool of blood" underneath his chair at an unspecified time during a home hemodialysis treatment on (b)(6) 2020.Following treatment, the patient went to hospital on (b)(6) 2020.Additional information was received on 08 oct 2020 from the home therapy nurse (htn) who stated approximately 100-200 ml of blood was found dried on the floor on (b)(6) 2020 and the patient reported to the emergency room with chest tightness.The patient was observed, lab values returned a hemoglobin of 7.7 g/dl and no medical intervention was provided.The patient was released same day, returning the following day to receive one unit of packed red blood cells.Following the event, the patient has recovered without sequelae and has resumed treatment with nxstage.

• 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: 10697368
• MDR Text Key: 211894976
• Report Number: 3003464075-2020-00068
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2020

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: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 73