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

Model Number RFP-401

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Septic Shock (2068)

Event Date 12/02/2022

Event Type  Death  

Manufacturer Narrative

The involved product was not received for evaluation.All devices meet quality criteria and manufacturing specifications prior to release.The nxstage pureflow solution instructions for use outlines risks associated with performing hemodialysis therapy and warns ¿the bag peel seam must be opened and the solution in the large chamber must be mixed with the solution in the small chamber before use to obtain the final dialysate suitable for hemodialysis.¿ and ¿failure to follow the mixing instructions may result in electrolyte imbalance or ph imbalance resulting in patient injury or death¿.

Event Description

A report was received on (b)(6) 2022 from the critical care nurse (ccn) of a patient admitted for septic shock and continued stating the patient passed away during a continuous renal replacement therapy (crrt) on (b)(6) 2022.Additional information was received on 08 dec 2022 from the ccn who stated the patient was connected to bicarbonate dialysate that had not been activated with an unknown amount used for treatment.The time of death was not specified and per the ccn, the cause of death has not been determined.

• 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: 15995241
• MDR Text Key: 305599270
• Report Number: 3003464075-2022-00088
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053286
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFP-401
• Device Catalogue Number: RFP-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death