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

Model Number	SAK-403
Health Effect - Clinical Codes	Burning Sensation (2146); Reaction (2414); Numbness (2415); Shaking/Tremors (2515)
Date of Event	08/16/2019
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.
Event or Problem Description
A report was received on (b)(6) 2019 from the caregiver of a (b)(6) year old male with end stage renal disease, anemia, and diabetes who experienced numbness in his arm, a burning sensation, and shivers 40 minutes into standard home hemodialysis treatment on (b)(6) 2019.The patient was taken to hospital where blood cultures showed no growth.Prophylactic antibiotics (nos) were administered, symptoms resolved, and the patient was discharged (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: 8945647
• Report Number: 3003464075-2019-00042
• Device Sequence Number: 2559607
• Product Code: FKR
• UDI-Device Identifier: M535SAK4030
• UDI-Public: +M535SAK4030/$$0920810792051
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K140571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019
• 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: 09/10/2020
• Device Model Number: SAK-403
• Device Catalogue Number: SAK-403
• Device Lot Number: 81079205
• 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: 08/19/2019
• Initial Report FDA Received Date: 08/29/2019
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 112
• Date Report Sent to FDA: 01/01/2005