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

Model Number CAR-170-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194)

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

The involved device was not received for evaluation.A device history record (dhr) review was conducted which revealed the product was released for distribution having met quality and manufacturing specifications and requirements.Initial review of the log file associated with the case has not identified a device malfunction.Review of the database for the involved lot number found no other reports of this nature associated with the device.User-facing documentation for the product provides information on the risks associated with dialysis therapy and suggested actions, instructions, cautions and warnings to enable patients to treat safely and effectively.It states that all treatments with the device must be administered under the responsibility of a physician and must be observed by a trained and qualified person.The trained and qualified person is warned to respond appropriately to all alarms and harmful conditions during treatment.

Event Description

A report was received on 24 mar 2022 from a 52 year old female patient with a medical history of end stage renal disease, stating she felt lightheaded when an unspecified amount of blood leaked from the device during a hemodialysis treatment on (b)(6) 2022.Additional information was received on 24 mar 2022 from the home therapy nurse (htn), who stated treatment was terminated, 911 was called and the patient was evaluated by emergency medical system (ems).The patient recovered without sequelae and no medical intervention was required.

Manufacturer Narrative

No product was received for evaluation and a malfunction was not confirmed.A review of the device history record confirmed the device met all quality criteria and manufacturing specifications prior upon release.A search of the complaint database for the involved lot number found no additional reports of blood leaks during treatment.The instructions for use includes information to reduce the risk of blood leaks and warns users that all treatments must be observed by a trained and qualified person.

• 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
• MDR Report Key: 14163486
• MDR Text Key: 298955338
• Report Number: 3003464075-2022-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$0723201770775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 20177077
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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
• Treatment: NX1373: NXSTAGE SYSTEM ONE FLUID DETECTION KIT.
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 104 KG