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

Model Number NX1000-1

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problem Anemia (1706)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

All product must meet quality requirements and manufacturing specifications prior to release.The nxstage system one user guide states a trained and qualified person must respond promptly and appropriately to all alarms and harmful conditions during treatment.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.There is no information to indicate that a malfunction occurred.

Event Description

A report was received on 27 sep 2020 from the home therapy nurse (htn) of a (b)(6) year old female patient with a medical history of anemia, end stage renal disease and approved for performing solo home hemodialysis therapy, stating the patient was unable to resolve a system generated alarm and elected to discard a blood circuit during a solo home hemodialysis treatment on (b)(6) 2020.Additional information was received on 29 sep 2020 from the htn who stated the patient was admitted to hospital with a diagnosis of "severe anemia" on (b)(6) 2020.Although requested, no information regarding the course of hospitalization was provided and the patient was discharged on (b)(6) 2020.Per the htn, the patient 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: 10719051
• MDR Text Key: 212548282
• Report Number: 3003464075-2020-00071
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 36