MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; NEEDLE, FISTULA

Model Number D9-2005MG

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.Instructions include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.Biocompatibility of the device has been established.Crane c, cunard ra, sweiss n, scanlon n, doherty ta, potok oa, anaphylaxis from ethylene oxide¿sterilized dialysis tubing and needles: a case report, american journal of kidney diseases (2023), doi: https://doi.Org/10.1053/j.Ajkd.2022.12.004.

Event Description

A report was received on 25 jan 2023 from a medical doctor (md) via a literature review regarding a 78-year-old male patient with end stage renal disease, chronic eosinophilia, and recent (10 days) transition from use of a tunneled dialysis catheter (tdc) to use of an arteriovenous fistula (avf), who became increasingly symptomatic while performing hemodialysis sessions with the dialysis tubing and needles.The patient was admitted to the intensive care unit for monitoring on an unspecified date.Additional analysis of the event by the md and involved medical team presented a differential diagnosis of anaphylaxis attributed to ethylene oxide (eto2) and its use in sterilization of the involved dialysis tubing and needles.Per the md, the patient¿s increased exposure to eto2 following transition to use of his avf activated an underlying sensitivity and the ensuing immune response.Following the diagnosis, the patient was pre-medicated prior to dialysis sessions with varied oral doses of antihistamines and corticosteroids and tolerated hemodialysis therapy using the tdc.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: NEEDLE, FISTULA
• 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: 16302839
• MDR Text Key: 308825758
• Report Number: 3003464075-2023-00015
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2023

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: D9-2005MG
• Device Catalogue Number: D9-2005MG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male