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

Model Number CAR-505

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded by the user and was not available for evaluation.A lot number for the cartridge was not provided.Without a lot number, a review of the device history record (dhr) could not be performed.Log files from the hemodialysis cycler were provided and analyzed for the event which confirmed the system was functioning as designed with alarms and cautions generated according to specifications.The available information does not indicate a device malfunction occurred.The instructions for use (ifu) warn that the cartridge has multiple connection points, and failure to make the proper connections can cause compromised treatment, blood loss, injury or death.The ifu outlines methods to reduce the risk of fluid or blood leaks, or accidental disconnections.A trained and qualified observer must check the system for blood and fluid leaks during treatment, pay close attention to the blood line and access connections, and keep vascular access sites and all cartridge connections visible throughout the treatment.

Event Description

A report was received on (b)(6) 2019 from a biomedical engineer regarding a critical care patient with history of acute kidney injury, stating the patient lost an unspecified amount of blood when the venous line disconnected from the patient's central venous catheter device during continuous renal replacement therapy (crrt) on (b)(6) 2019.The patient¿s blood pressure decreased (values not provided) and was stabilized with increased vasopressors (nos) and discontinuation of crrt.Additional information was received on 29 jul 2019 from the nurse manager stating a transfusion of 2 units of packed red blood cells was required and the patient recovered without sequelae.

• 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: 8911657
• MDR Text Key: 155027115
• Report Number: 3003464075-2019-00041
• Device Sequence Number: 1
• Product Code: KDI
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/01/2005,08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Was Device Available for Evaluation?: No
• 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
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention