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

Model Number CAR-172-C

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem Blood Loss (2597)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

The cartridge was not available for evaluation.A review of the device history record (dhr) was performed and revealed no related defects were found during the manufacturing and the lot was released for distribution having met all product design requirements.There is no information to indicate that a malfunction occurred.The reported event is consistent with a use issue and not a product malfunction.The instructions for use (ifu) warns the operator to secure caps and close clamps after priming and after each use to prevent blood loss.Biocompatibility has been established.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2018 from a physician regarding a (b)(6) female patient with a history of heart failure (nos) who was found unconsciousness (time unconscious and time into treatment before losing consciousness unknown) during a standard home hemodialysis treatment on (b)(6) 2018.Blood loss of approximately 250-500 ml was found leaking from the unclamped heparin line.The patient was admitted to the intensive care unit (icu) and hospitalized from (b)(6) 2018 with a hemoglobin of 6.7 g/dl and hematocrit of 0.209.Treatment included volume support (nos) without blood transfusion or use of vasopressors.The physician stated the reported event was due to a use issue, as the patient did not clamp the heparin line, or secure the caps.The patient recovered without sequelae and continues to treat using nxstage products and therapy at a dialysis facility.

• 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: 7876307
• MDR Text Key: 120249509
• Report Number: 3003464075-2018-00037
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0819801770128
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 80177012
• 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: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 58