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

Model Number CAR-172-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dizziness (2194); Blood Loss (2597)

Event Date 01/03/2021

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded by the patient and was not available for evaluation.A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.The nxstage system one user guide (ug) states a trained and qualified person must respond promptly and appropriately to all alarms and harmful conditions during treatment.The ug supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.The ug also warns the user to test the fluid leak sensor alarm prior to treatment.

Event Description

A report was received on 29 jan 2021 from the home therapy nurse (htn) of a (b)(6) year old male with multiple comorbidities including end stage renal disease and anemia of chronic kidney disease, approved for performing solo home hemodialysis therapy, stating the patient experienced dizziness following an unspecified amount of blood loss during a home hemodialysis session on (b)(6) 2021.Per the htn the patient stated the blood loss was ¿coming from the filter¿ and the patient attended hospital to receive a blood transfusion.Additional information was received on 01 feb 2021 from the htn, who stated that the patient was transfused in the emergency department with one unit of packed red blood cells and released to home same day, (b)(6) 2021.No further details of the blood loss were provided, the patient recovered without sequelae and continues to treat using the nxstage system.

• 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: 11275886
• MDR Text Key: 233501825
• Report Number: 3003464075-2021-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0422007770463
• 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: 02/03/2021

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 Expiration Date: 04/01/2022
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 00777046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 104