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

Model Number SLE-3010M3096

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Respiratory Distress (2045); Swelling (2091); Loss of consciousness (2418); Respiratory Failure (2484)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The cartridge was not retained for investigation. The design history file for the cartridge lot number was reviewed and met all requirements in the manufacturing process prior to release with no related defects. All available information supports that the product was functioning as designed and there was no malfunction. The user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions. Biocompatibility of the device has been established. (b)(4) considers this report closed. No additional information will be provided. (b)(4).

Event Description

A report was received of a (b)(6) male patient who experienced shortness of breath, acute respiratory failure with airway edema, lip and tonsillar swelling during hemodialysis treatment in center. Symptoms developed 17 minutes after treatment commenced on (b)(6) 2017. The patient became unresponsive to verbal command and sternal rub. Benadryl, 50mg, intravenous was administered. The patient was transported to the hospital where he was intubated and mechanically ventilated. Epinephrine (route and dose unspecified), solumedrol 125mg and famotidine were administered. The patient was transferred to intensive care and was discharged from the hospital on (b)(6) 2017. The physician summary stated the patient symptoms were inconsistent with a diagnosis of anaphylaxis alone. The patient''s lisinopril was discontinued as a potential risk factor.

• 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 ; 9786874700
• MDR Report Key: 6352329
• MDR Text Key: 68102753
• Report Number: 2919260-2017-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/01/2017
• Device Model Number: SLE-3010M3096
• Device Catalogue Number: STREAMLINE EXPRESS, 8MM, GAMMA
• Device Lot Number: 60956001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/23/2017 Patient Sequence Number: 1

Treatment

LISINOPRIL