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

Model Number	SAK-403
Health Effect - Clinical Codes	Fever (1858); Headache (1880); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Tachycardia (2095); Tingling (2171); Chills (2191); Numbness (2415); Lethargy (2560)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record (dhr) for the involved dialysate sack lot was conducted which confirmed the product met all quality criteria and manufacturing specifications prior to release.There is no evidence to suggest that a product malfunction occurred.The user guide provides instruction to maintain aseptic technique and warnings to follow instructions provided to prevent the risk of exposure to infectious diseases.Biocompatibility of the device has been established.Nxstage medical considers this report closed.No additional information will be provided.
Event or Problem Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) of a (b)(6) male with multiple comorbidities including end-stage renal disease (esrd) and elevated liver function tests (lft), who experienced headache, fever (104.5 f), tachycardia (117 bpm), numbness/tingling in his fingers, lower back pain, chills, hypotension (98/58), and increased lethargy approximately 50 minutes after initiating his first in-center hemodialysis treatment with the dialysate sack on (b)(6) 2019.Therapy was terminated, intravenous (iv) vancomycin (1.5g) & ceftazidime (1.5g) were administered, and the patient become unresponsive.Nasal oxygen (o2) was applied, and the patient was transported via ambulance and admitted to the intensive care unit (icu).Additional information received on (b)(6) 2019 from the htn revealed that evaluation in hospital included blood and stool cultures with no organism identified.Viral syndrome was suspected, and the iv antibiotics were ceased.Further blood tests, electrocardiogram (ekg) and chest x-ray (cxr) revealed no causative factors.The patient received a diagnosis of sepsis with acute organ dysfunction and was discharged in stable condition on (b)(6) 2019.

• 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: 8579662
• Report Number: 3003464075-2019-00014
• Device Sequence Number: 1586666
• Product Code: FKR
• UDI-Device Identifier: M535SAK4030
• UDI-Public: +M535SAK4030/$$1220901792854
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140571
• 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): 05/03/2019
• 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: Lay User/Patient
• Device Expiration Date: 12/16/2020
• Device Model Number: SAK-403
• Device Catalogue Number: SAK-403
• Device Lot Number: 90179285
• 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: 04/17/2019
• Initial Report FDA Received Date: 05/03/2019
• 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: Hospitalization
• Patient Age: 28 YR
• Date Report Sent to FDA: 01/01/2005