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

Model Number NX1000-5-A

Device Problem Improper Flow or Infusion (2954)

Patient Problems Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 09/30/2022

Event Type  Injury  

Event Description

A report was received on 06 oct 2022 from the health care professional (hcp) of a 67 year old patient, who stated an inaccurate amount of programmed fluid was removed during a continuous veno-venous hemofiltration (cvvh) treatment on (b)(6) 2022.Additional information was received on 08 dec 2022 from the hcp stating the patient experienced fluid overload with worsening pulmonary edema requiring oxygen, chemical paralysis, and an increase in sedation.Per the hcp, symptoms improved upon switching to a different cycler for cvvh therapy.

Manufacturer Narrative

The involved device was not received for evaluation.The device history record (dhr) was reviewed and confirmed the device met all quality criteria and manufacturing specifications prior to release.Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable.There was no indication of a device malfunction from the available information.When in critical care, the patient¿s hemodynamic, fluid, and electrolyte balance must be monitored regularly, and their total fluid balance must account for weighing technique, scale accuracy, fluid consumption and output.Patients in critical care have multiple potential sources of fluid input as part of their care plan which impact their fluid balance status.The user guide states that all treatments must be administered under a physician¿s prescription.A trained and qualified person must observe all treatments to monitor vital signs in response to therapy, their general well-being and physical status, and to promptly respond to harmful conditions that may occur.(b)(4).User facility report #: (b)(4).

Manufacturer Narrative

Corrected date entered into g3: date received by manufacturer.

• 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: 15986296
• MDR Text Key: 305506127
• Report Number: 3003464075-2022-00087
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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 Model Number: NX1000-5-A
• Device Catalogue Number: ACUTE CYCLER 3RD EDITION, ROH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention