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

Model Number NX1000-3-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); Test Result (2695)

Event Date 06/15/2020

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.Udi: (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 patient with a medical history of hypertension and end stage renal disease, who stated the patient had abnormal lab values and subsequently discontinued use of the device on (b)(6) 2020.Additional information was received on 27-28 jul 2020 from the htn who stated the patient elected to discard blood (amounts not specified) while troubleshooting alarms.In (b)(6) 2020 (date not provided) the patient had a hemoglobin of 7g/dl and received a blood transfusion.No additional information has been received.

• 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: 10430294
• MDR Text Key: 203643690
• Report Number: 3003464075-2020-00051
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• 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: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 110