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 Hemorrhage/Bleeding (1888); Nausea (1970); Dizziness (2194)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

The involved cartridge was discarded and 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.Available log files were retrieved and analyzed which showed the cycler performed as designed and intended, and alarmed appropriately when alarm conditions were present.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment.

Event Description

A report was received on 14 oct 2021 regarding a (b)(6) year old male with a medical history including end stage renal disease and recent (nos) lower gastrointestinal bleed, who stated an unspecified amount of blood leaked during a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 15 oct 2021 and 18 oct 2021 from the home therapy nurse (htn) who stated the care partner reported a ¿large amount¿ of dried blood was seen on the floor by the cycler.The patient felt nauseous, weak, and lightheaded.Emergency medical services (ems) were called who transported the patient to hospital where they were admitted on (b)(6) 2021.Per the htn, the patient¿s hemoglobin was 4.9g/dl and 6 units of packed red blood cells (prbc) were given.The patient stabilized and was discharged from the hospital on (b)(6) 2021 for re-training before resuming hemodialysis treatment with the nxstage device.

• 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: 12744711
• MDR Text Key: 280053919
• Report Number: 3003464075-2021-00064
• Device Sequence Number: 1
• Product Code: KDI
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 10477031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 99