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

Model Number CAR-172-C

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194); Respiratory Insufficiency (4462)

Event Date 09/20/2022

Event Type  Injury  

Event Description

A report was received on 23 sep 2022 from the home therapy nurse (htn) of a (b)(6) year old female with a medical history including multiple comorbidities and end stage renal disease, who stated the patient experienced an estimated blood loss of 100mls due to an unclamped heparin infusion line during a hemodialysis treatment on (b)(6) 2022.Emergency medical services were called and the patient was transported to hospital, where she was admitted on (b)(6) 2022 and discharged on (b)(6) 2022.Additional information was received on 27 sep 2022 from the htn who stated the patient experienced feeling lightheaded and short of breath.Per htn, the blood leak is due to use error and originated from the heparin line not being clamped.The patient has recovered without sequelae and has resumed therapy with the nxstage system.

Manufacturer Narrative

The involved cartridge was not received for evaluation.All devices must meet all quality criteria and manufacturing specifications prior to release.The instructions for use provides information and warnings associated with performing hemodialysis therapy.It warns the user to secure caps and close clamps prior to use to prevent air entry or blood loss.

• 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: 15578986
• MDR Text Key: 301554277
• Report Number: 3003464075-2022-00061
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 10/11/2022

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 Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 67 KG