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 Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Pain (1994); Swelling (2091); Hypovolemia (2243); Blood Loss (2597); No Code Available (3191)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

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.The log file for the event was received and analyzed, confirming the treatment proceeded uneventfully and was terminated with automated rinseback.There was no indication of a device malfunction.

Event Description

A report was received on (b)(6) 2020 from a health care professional regarding a (b)(6)year old female with end stage renal disease who experienced fatigue, pallor and hypotension (77/57 mmhg) during a hemodialysis treatment on (b)(6) 2020.The nurse elected to terminate treatment and automated rinseback was performed successfully.On removing the cartridge, the nurse noted approximately 200ml of blood loss, the source of which could not be determined.The patient attended the emergency room later that day with pain and swelling in her arteriovenous fistula (avf).Additional information was received on 01 sep 2020 from a health care professional who stated the patient was hypovolemic and their hemoglobin decreased from 8.7 g/dl to 5.6 g/dl.The patient was observed overnight and released with no medical intervention reported.

• 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: 10501222
• MDR Text Key: 205888994
• Report Number: 3003464075-2020-00059
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0921912770103
• 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: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/08/2020

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: 09/01/2021
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 91277010
• 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: 08/10/2020
• Initial Date FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 81