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

Model Number CAR-500

Device Problem Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2022

Event Type  Injury  

Event Description

A report was received on 14 nov 2022 from the risk manager of a patient of unspecified pathology, stating alarms were unable to be resolved when priming for a continuous veno-venous hemofiltration treatment on (b)(6) 2022.Additional information was received on 27 dec 2022 from the risk manager who stated the patient received "blood products" due to multiple filter changes, with no further details provided.

Manufacturer Narrative

The cartridge was received for evaluation and successfully passed testing.A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.The instructions for use states "all treatments must be administered under a physician¿s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician." user facility report #: (b)(4).

• 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: 16132146
• MDR Text Key: 307021300
• Report Number: 3003464075-2023-00004
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$022310678019T
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2023

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: 02/01/2023
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 10678019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• 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
• Patient Outcome(s): Required Intervention