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

Model Number CAR-500

Device Problem Material Rupture (1546)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded and was not available for evaluation.All product is released having met all manufacturing specifications and quality 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.

Event Description

A report was received on (b)(6) 2021 from the coronary care unit (ccu) nurse manager (nm) of an (b)(6)-year-old female patient with heart failure and acute kidney injury, stating that the filter ruptured resulting in an estimated blood loss of 250ml during a continuous renal replacement therapy (crrt) on (b)(6) 2021.Additional information was received on 06 may 2021 from the ccu nm stating that the patient had a hemoglobin decrease of approximately 1 gram (exact number not provided) and received one unit of blood.Following the event, the patient has recovered to the baseline status of admission to the ccu.

• 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: nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 11815548
• MDR Text Key: 254046262
• Report Number: 3003464075-2021-00023
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133547
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• 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): Required Intervention
• Patient Age: 86 YR