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

Model Number CAR-505

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the involved cartridge confirmed the venous connector was broken.The lot was released for distribution having met all product design, quality and product released criteria.No defects were found during incoming inspection of this lot.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on march 6, 2017 regarding a critical care patient where the venous tip of the luer broke off in the patient¿s catheter.There was no reported adverse event and no report that medical intervention was required.

Event Description

Additional information was received on april 10, 2017.A (b)(6) male patient was receiving crrt on (b)(6) 2016 and when the nurse attempted to disconnect the venous line from the patient's access the venous port broke inside the patient's catheter.The patient's dialysis catheter was removed as the patient remained stable and was discharged.

• 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 ; 9786874700
• MDR Report Key: 6459798
• MDR Text Key: 72178338
• Report Number: 3003464075-2017-00021
• Device Sequence Number: 1
• Product Code: KDI
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 60578001
• Other Device ID Number: +M535CAR5050/$$021860578001X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 95