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

Model Number CAR-171-C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling (2091)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.Biocompatibility has been established.There is no information to indicate that a malfunction occurred.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 nurse regarding a (b)(6) female, with medical history significant for a recent reaction during their previous short daily hemodialysis treatment, who became symptomatic during rechallenge on (b)(6) 2018.Within 2 minutes of treatment commencing, the patient experienced itchiness of the head, back and arms, and facial flushing.10mg iv chlorphenamine was administered.The patient then experienced generalized itching and lip swelling.200mg hydrocortisone and 0.5mg epinephrine were given intravenously and no further symptoms were reported.The patient was observed in the facility for 6 hours and recovered without sequelae.The following day dialysis therapy was performed using a conventional hemodialysis device from another manufacturer 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: 8050862
• MDR Text Key: 126545226
• Report Number: 3003464075-2018-00058
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0320806770355
• 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: 01/01/2005,11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: CAR-171-C
• Device Catalogue Number: CAR-171-C
• Device Lot Number: 80677035
• 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: 10/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 62