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

Model Number CAR-505

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 12/16/2018

Event Type  Injury  

Manufacturer Narrative

The cartridge was not returned for evaluation and a lot number was not provided.Without a lot number, a device history review (dhr) could not be performed.An evaluation of the cartridge was not possible.Biocompatibility has been established.There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.The nxstage system one user's guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and also includes warnings to observe the patient and monitor physical status for potential complications.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 11 feb 2019 regarding a (b)(6) female with unspecified comorbidities who became hypotensive and pulseless after initiation of continuous renal replacement therapy (crrt) on (b)(6) 2018.The patient required cpr with two doses (nos) of intravenous epinephrine administered.The patient improved and was hospitalized.Intravenous norepinephrine was commenced.Additional information was received from the attending physician on (b)(6) 2019 stating the patient recovered from the episode and remains in the hospital.Additional information was requested but has not been received.

Manufacturer Narrative

No product was received for evaluation.A review of the device history record (dhr) of the reported lot number confirmed no related defects were found during the manufacturing and the lot was released for distribution having met all product design requirements.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 8377602
• MDR Text Key: 137379599
• Report Number: 3003464075-2019-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K133547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 81078013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR