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

Model Number	CAR-500
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility report #: (b)(4).The cartridge was discarded and not available for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.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 or Problem Description
A report was received on (b)(6) 2021 from the risk manager of a critical care facility regarding a (b)(6) male patient, who stated that a therapy fluid leak was present during a continuous veno-venous hemofiltration (cvvh) treatment on (b)(6) 2021.The patient¿s blood was unable to be returned and the patient was given a transfusion of unit of packed red blood cells.Although requested, additional information has not been provided.

• Brand Name: NXSTAGE SYSTEM ONE
• Common Device Name: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 12341276
• Report Number: 3003464075-2021-00038
• Device Sequence Number: 3973900
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$112210378002H
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 10378002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 37