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

Model Number CAR-505

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Rash (2033); Respiratory Distress (2045); Urticaria (2278)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

The cartridge was not returned for evaluation and a lot number was not provided.Without a lot number, a device history review (dhr) could not be performed.An evaluation of the cartridge was not possible.Biocompatibility has been established.There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.The nxstage system one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and the instructions for use include warnings to observe the patient and monitor physical status for potential complications.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 5 apr 2018 from an intensive care nurse regarding a (b)(6) female with a medical history that included systemic lupus, synovitis and a known hypersensitivity to polysulfone dialyzers, who experienced symptoms while receiving continuous veno-venous hemodialysis (cvvh).The patient was premedicated with intravenous solumedrol/100 and benadryl/50 prior to therapy with the nxstage system one.Two hours after treatment commenced, the patient exhibited hives, rash, respiratory distress, tachypnea with wheezing, increased oxygen requirement and agitation.Treatment was changed to a dialyzer from a different manufacturer and no further issues were reported.

• 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: 7426018
• MDR Text Key: 105327735
• Report Number: 3003464075-2018-00018
• 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
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/12/2018
• 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): Life Threatening
• Patient Age: 30 YR