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

Model Number CAR-170-C

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Reaction (2414); No Code Available (3191)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

The cartridge was not retained for investigation.The device history record (dhr) for the cartridge lot number provided was reviewed and supports that no related defects were found during the manufacturing of this lot.All available information supports that the product was functioning as designed and there was no malfunction.The user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on july 18, 2017 from a home therapy nurse regarding a (b)(6) year old male patient.It was reported that approximately 5-10 minutes into a standard hemodialysis treatment on (b)(6) 2017 the patient experienced difficulty breathing and became unresponsive.Symptoms persisted for approximately 15 minutes and the patient was transferred to hospital without medical intervention.He was admitted and received hemodialysis with a dialyzer from a different manufacturer.No other treatment was required.He was discharged on (b)(6) 2017 with a discharge diagnosis of ''type a dialyzer reaction''.The patient continues to treat without event using the nxstage system and a dialyzer from the third party manufacturer.

• 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: 6755094
• MDR Text Key: 81465515
• Report Number: 3003464075-2017-00034
• Device Sequence Number: 1
• Product Code: KDI
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 70577042
• Other Device ID Number: +M535CAR170C0/$$0119705770425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 99