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

Model Number CAR-172-C

Device Problem Backflow (1064)

Patient Problem Hemolysis (1886)

Event Date 01/25/2020

Event Type  Injury  

Manufacturer Narrative

There was no response to the request for information and the device was not received for evaluation.There was no confirmed device malfunction.The car-172-c instructions for use provides information and warnings for use of the device including potential causes and prevention of hemolysis.A trained and qualified person must observe all treatments, inspect the bloodlines before and during use and respond to conditions such as clotting during treatment.The nxstage system one user guide includes hemolysis as a potential risk associated with dialysis therapy and states that an underlying medical condition or medication may cause hemolysis or alter normal effluent appearance.

Event Description

A report was received on (b)(6) 2020 from the distributor regarding a male patient who observed blood in the dialysate line and experienced unspecified symptoms of hemolysis during a standard home hemodialysis treatment on (b)(6) 2020.The patient was subsequently hospitalized.Although requested, additional information has not been provided.

Manufacturer Narrative

A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications.Biocompatibility has been established.(b)(4).

Event Description

A report was received on 27 jan 2020 from a healthcare professional of a 57 year old male patient with chronic renal failure and hypertension, who stated the patient experienced hemolysis symptoms during hemodialysis treatment, blood was observed in the dialysate line and the patient was hospitalized.Follow up information was received on 13 feb 2020 from a healthcare professional which revealed the patient experienced abdominal pain, nausea and dizziness approximately one hour into treatment on (b)(6) 2020.Blood tinged fluid was visualized in the dialysate effluent line, the patient ended treatment without rinseback and was admitted to hospital on (b)(6) 2020.Treatment in hospital included a blood transfusion and conventional hemodialysis with no other details provided.The patient recovered without sequelae and was discharged on (b)(6) 2020 with a diagnosis of hemolysis.On (b)(6) 2020 the patient resumed home hemodialysis treatment with the nxstage system one.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 9701260
• MDR Text Key: 182909841
• Report Number: 3003464075-2020-00009
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2021
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 90777049
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR