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

Model Number CAR 172-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Toxicity (2333)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

The device was not retained for investigation.A lot number was not identified.All available information supports that the product was functioning as designed and there was no malfunction.Biocompatibility of the device has been established.The nxstage user guide includes platelet decrease as a potential risk associated with dialysis treatments.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received that a (b)(6) female with a history of cardiomyopathy and heart transplant experienced a decrease in platelets after receiving standard hemodialysis.On an unspecified date a large bruise, approximately 3 inches by 2 inches, was noted on the back of the thigh.No medical intervention was required.

• 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: 6420300
• MDR Text Key: 70424508
• Report Number: 3003464075-2017-00017
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CAR 172-C
• Device Catalogue Number: CAR 172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• 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
• Treatment: THE PATIENT WAS RECEIVING DALTEPARIN
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 62