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 High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Anxiety (2328); No Code Available (3191)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The patient experienced a similar adverse event with the same device model number on 27 jul 2020.The event is documented in mfr report # 3003464075-2020-00055.All devices must meet 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 Description

A report was received on 30 jul 2020 from the physician of a (b)(6) year old male in critical care for unspecified pathology, with multiple comorbidities including known dialyzer reactions during dialysis therapy, who experienced symptoms 10 ¿ 15 minutes into continuous renal replacement therapy in (b)(6) 2019 (date not provided).Symptoms included change of taste, tachypnea, labile pulse, hypoxia, hypertension, and anxiety.Additional information has been requested and has not been provided.

• 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: 10439163
• MDR Text Key: 204696911
• Report Number: 3003464075-2020-00054
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• 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: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR