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

Model Number CAR-172-C

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

Patient Problem Exsanguination (1841)

Event Date 03/20/2022

Event Type  Death  

Manufacturer Narrative

The cartridge was not received 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 states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.There was no indication of a device malfunction from the available information.

Event Description

A report was received on 29 mar 2022 from the health professional of a (b)(6) male patient with a medical history including multiple comorbidities and chronic kidney disease, who stated the patient was found expired on (b)(6) 2022 following an intended hemodialysis treatment on (b)(6) 2022.An unspecified amount of blood loss was noted in a ¿puddle¿ on the floor.Although requested, additional information was not provided.

Event Description

Confirmation of dates: (b)(6) 2022 standard hemodialysis treatment attempted and not completed.Available information supports that the patient expired during this attempt.(b)(6) 2022 patient found in their home by healthcare professionals with an improperly connected dialysis device, further supporting the date of death as (b)(6) 2022.

Manufacturer Narrative

On 20 may 2022 a request was received from the fda regarding the date provided for the patient death.Additional information is provided to clarify the correct date of death as (b)(6) 2022.

• 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
• MDR Report Key: 14167541
• MDR Text Key: 292735826
• Report Number: 3003464075-2022-00013
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

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: 11/01/2022
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 10377005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 97 KG