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

Model Number	CAR-505
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tachycardia (2095); Anxiety (2328); Increased Respiratory Rate (2486); No Code Available (3191)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient experienced a similar adverse event with the same device model number in (b)(6) 2019 (date not provided).The event is documented in mfr report # 3003464075-2020-00054.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.Monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.Biocompatability has been established.
Event or Problem Description
A report was received on 30 jul 2020 from the physician of a (b)(6) year old male in critical care for treatment of pericardial effusion and fluid overload, with multiple comorbidities including known dialyzer reactions during dialysis therapy, who experienced symptoms 10 ¿ 15 minutes into continuous renal replacement therapy on (b)(6) 2020.Symptoms included change of taste, tachypnea, labile pulse, hypoxia, hypertension, and anxiety.Additional information was received on 5 aug 202 from the physician stating the patient¿s oxygen level dropped from ~90% to 67%, systolic blood pressure increased from 100mmhg to 144mmhg, heart rate increased from 110bpm to 140bpm and respiratory rate increased from ~30 to 40/m.25mg benadryl was administered intravenously to address the symptoms.

• 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: 10439148
• Report Number: 3003464075-2020-00055
• Device Sequence Number: 2795731
• Product Code: KDI
• UDI-Device Identifier: M535CAR5050
• UDI-Public: +M535CAR5050/$$122100478027T
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 01/01/2005

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: 12/01/2021
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 00478027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/21/2020
• 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: Other
• Patient Age: 24 YR
• Date Report Sent to FDA: 01/01/2005