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

Model Number CAR-172-C

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

Patient Problems Dyspnea (1816); Tingling (2171); Shaking/Tremors (2515)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

The involved cartridge was not returned for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.Biocompatability has been established.This report and the information contained herein is submitted to the applicable competent authority under medical device directive 93/42/eec and represents the information available to the company at the time of the report.

Event Description

A report was received on 07 jun 2019 from the physician regarding a (b)(6) male, with a recent history of respiratory difficulty during hemodialysis treatment, who experienced respiratory difficulty, chest pain, tremor, and tingling lips at the time of connection during their second hemodialysis treatment with the nxstage system on (b)(6) 2019.Additional information was received on (b)(6) 2019 from a pharmacist stating treatment was terminated after approximately 50 minutes and the patient was treated with oral polaramine (dose unspecified).The patient recovered without sequelae and has discontinued receiving hemodialysis treatment using nxstage product and therapy.

• 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: 8723520
• MDR Text Key: 148818005
• Report Number: 3003464075-2019-00029
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$1019802770357
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/21/2019

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 Expiration Date: 10/01/2019
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 80277035
• 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
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 45