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

Model Number NX1000-5-A

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/13/2019

Event Type  Injury  

Manufacturer Narrative

The device was evaluated on site by a qualified biomedical engineer and was found to be functioning as designed and intended with no trouble found. 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. Udi: (b)(4).

Event Description

A report was received on 31 oct 2019 from a healthcare professional regarding a patient with unknown comorbidities who was in critical care unit for an unspecified medical condition, stating rinseback of the patient¿s blood following extracorporeal hemodialysis therapy could not be completed. The patient sustained a blood loss, amount not provided, and received a blood transfusion on (b)(6) 2019. Additional information was received on 19 nov 2019 from the biomedical engineer, who stated the device was evaluated and found to be functioning as designed and intended with no trouble found. No additional information or treatment details were provided.

• 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: 9355846
• MDR Text Key: 167620887
• Report Number: 3003464075-2019-00063
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/01/2005,11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NX1000-5-A
• Device Catalogue Number: ACUTE CYCLER 3RD EDITION, 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
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/21/2019 Patient Sequence Number: 1