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

Model Number NX1000-1

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

Patient Problems Hypervolemia (2664); Test Result (2695)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

The involved cycler was not received for evaluation.The cycler serial number was not provided.Without a serial number, a review of the device history record (dhr) was unable to be performed.

Event Description

A report was received on (b)(6) 2019 from the home therapy nurse (htn) of a (b)(6) year old male with a medical history of type ii diabetes with other diabetic kidney complications (nos), iron anemia in chronic kidney disease (ckd), iron deficiency anemia, hypertensive ckd with stage 5 ckd, and secondary hyperparathyroidism of renal origin, stating the patient was admitted to hospital on (b)(6) 2019 with volume overload and elevated cardiac enzymes.Additional information was received on (b)(6) 2019 from the htn stating the patient remains hospitalized at this time.Per the htn, there is no indication of a device malfunction and the physician stated the patient required reassessment of their dry weight.Although requested, no further information has been received.

• 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: 9347323
• MDR Text Key: 167181084
• Report Number: 3003464075-2019-00060
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• 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: 01/01/2005,11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 89