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

Model Number	CAR-500
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Reaction (2414); Low Oxygen Saturation (2477)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.There is no information to indicate that a malfunction occurred.The instructions for use warn that the device must be used under the prescription of a physician.The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.The patient¿s blood pressure, vital signs, general well-being, and physical status should be monitored closely throughout the treatment.Biocompatability has been established.
Event or Problem Description
A report was received on (b)(6) 2021 from the nurse of a (b)(6) old female in the critical care unit status post cardiac arrest with cardiogenic shock including hypotension requiring vasoactive medications, who stated the patient experienced tachycardia and hypotension approximately five minutes into their first continuous renal replacement therapy (crrt) session on (b)(6) 2021.Additional information was received on 12 jan 2021 from the nurse who stated the patient also desaturated, with oxygen (o2) levels decreasing from 99-100% to 40-60%.Symptoms improved with administration of 1 mg intravenous epinephrine, sodium bicarbonate (dose not provided) and 100% fio2.The patient was rechallenged with the device later that day, after being premedicated with intravenous diphenhydramine, methylprednisolone and famotidine, doses unspecified and experienced no further reaction.

• 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: 11242944
• Report Number: 3003464075-2021-00003
• Device Sequence Number: 17125494
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$052200978004R
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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: 05/01/2022
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 00978004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2021
• 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: 55 YR