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

Model Number CAR-172-C

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

Patient Problems Itching Sensation (1943); Nausea (1970); Swelling (2091); Vomiting (2144); Loss of consciousness (2418); Sweating (2444); Diminished Pulse Pressure (2606)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

There is no indication of a device malfunction.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.The device meets all quality criteria and manufacturing criteria and specifications prior to release.Biocompatibility has been established.The user guide and instructions for use include allergic reaction as a potential risk associated with dialysis treatments and also include warnings to monitor for potential allergic reactions.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2018 from a healthcare professional regarding a (b)(6) female with a recent history of myocardial infarction and hypotension during conventional hemodialysis, who became symptomatic during their first short daily hemodialysis treatment using the involved device on (b)(6) 2018.Within ten minutes of commencing treatment, the patient began to feel itchy and had facial flushing with a blood pressure (bp) of 112/80 and heart rate (hr) of 110 beats per minute.An unspecified volume of saline was administered without improvement.The patient experienced additional symptoms including nausea and vomiting, which progressed to unresponsiveness, diaphoresis, lip swelling, fixed pupils and a blood pressure that could not be obtained.A further volume of saline (800ml) was administered with some improvement (bp 117/78, hr 33) and emergency services attended.The patient received two epipen injections, two doses of adrenaline (nos) and was hospitalized.She recovered without sequelae and received hemodialysis with a conventional hemodialysis device from another manufacturer on (b)(6) 2018 without issue.

• 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: 8010336
• MDR Text Key: 125199524
• Report Number: 3003464075-2018-00056
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,10/26/2018

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: Lay User/Patient
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• 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
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR