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

Model Number SAK-403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Headache (1880); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Tachycardia (2095); Tingling (2171); Chills (2191); Numbness (2415); Lethargy (2560)

Event Date 04/12/2019

Event Type  Injury  

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 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
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 8579662
• MDR Text Key: 144122579
• Report Number: 3003464075-2019-00014
• Device Sequence Number: 1
• Product Code: FKR
• UDI-Device Identifier: M535SAK4030
• UDI-Public: +M535SAK4030/$$1220901792854
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 28 YR