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

Model Number CAR-125-B

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

Patient Problems Anemia (1706); Asthma (1726); High Blood Pressure/ Hypertension (1908); Seizures (2063); Thrombosis (2100)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

The cartridge was received for evaluation and passed all testing with no trouble found.The involved dialyzer is from a different manufacturer and was not evaluated by nxstage.The device history record for the product was reviewed which confirmed the cartridge was released meeting all quality and manufacturing requirements.Biocompatibility has been established.

Event Description

A report was received on 8 oct 2019 from the home therapy nurse (htn), regarding an (b)(6) male with multiple comorbidities including asthma, inferior vena cava thrombosis, clotting disorder, anemia, hypertension, seizures, polycystic kidney and transplant failure who had pink-tinged effluent that tested negative for blood during standard home hemodialysis therapy on (b)(6) 2019.Per the htn treatment was terminated and the patient was taken to hospital by the caregiver for precautionary observation.Additional information was received 08 oct 2019 - 30 oct 2019 from the htn which revealed the patient was admitted to hospital from (b)(6) 2019 for blood tests and cultures (nos) which were unremarkable.The patient did not experience symptoms and received dialysis while hospitalized with no additional events reported.

• 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: 9268126
• MDR Text Key: 165946613
• Report Number: 3003464075-2019-00058
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR125B0
• UDI-Public: +M535CAR125B0/$$0121902770482
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2021
• Device Model Number: CAR-125-B
• Device Catalogue Number: CAR-125-B
• Device Lot Number: 90277048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• 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
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR
• Patient Weight: 24