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

Model Number CAR-170-C

Device Problem Insufficient Information (3190)

Patient Problems Loss of consciousness (2418); Ambulation Difficulties (2544); Blood Loss (2597)

Event Date 07/22/2018

Event Type  Injury  

Manufacturer Narrative

The device was not retained for investigation.A device history record (dhr) review for the cartridge was conducted and revealed the product was released having met all design and acceptance requirements, and all manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.Nxstage user guides and instructions for use warn the user to close all clamps to prevent blood loss and to have a trained and qualified observer check the system for blood and fluid leaks during treatment especially when the patient is connected and disconnected.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 26 jul 2018 from a home training nurse (htn) regarding a (b)(6) male with a medical history significant for balance and mobility issues, who experienced blood loss (nos) and lost consciousness during his standard home hemodialysis treatment on (b)(6) 2018.The htn stated the blood loss occurred from the arterial line due to a clamp that was not closed.The patient was transported to the hospital where he was admitted and received two units of packed red blood cells (prbc).The patient was discharged on (b)(6) 2018 in stable condition and resumed standard hemodialysis treatments on (b)(6) 2018.

• 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 ; 9786875276
• MDR Report Key: 7761468
• MDR Text Key: 116388864
• Report Number: 3003464075-2018-00029
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$1219804770157
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140526
• 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: 01/01/2005,08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2019
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 80477015
• 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: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 87