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 Congestive Heart Failure (1783); Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

There was no indication of a device malfunction.No lot number was provided so review of the device history record could not be conducted.All devices must meet quality requirements and manufacturing specifications prior to release.Bio-compatibility has been established.The instructions for use warns that the device must be used under the prescription of a physician.The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.

Event Description

A report was received on (b)(6) 2020 from the nurse regarding a (b)(6) year old male patient with a complex medical history including decompensated cardiogenic / septic shock, acute kidney injury and congestive heart failure who experienced a platelet decrease during continuous renal replacement therapy (crrt) with the nxstage system.Additional information was received on 08 jun 2020 from the nurse who stated crrt was performed using the nxstage device from (b)(6) 2020 with platelets ranging from 85,000 ¿ 162,000/mcl during this time.Per the nurse, the patient was given plasma, platelets and packed red blood cells during treatment, amounts, dates and times not 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: 10190995
• MDR Text Key: 196404226
• Report Number: 3003464075-2020-00032
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR