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 Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

All devices must meet quality requirements and manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.The nxstage user guide and instructions for use include platelet decrease as a potential risk associated with dialysis therapy and also include warnings to monitor for potential platelet decrease.Biocompatability has been established.

Event Description

A report was received on 23 apr 2021 from a healthcare professional (hcp) via literature regarding a patient with unspecified pathology stating the patient experienced a decrease in platelet count and tracheal bleeding after performing hemodialysis treatments with the device on unspecified dates.Per the hcp, the patient changed to a dialyzer from a different manufacturer and the platelet level improved.The patient continues to perform treatments with the nxstage system one with no further symptoms reported.

Event Description

A report was received on (b)(6) 2021 from a healthcare professional (hcp) via literature regarding a patient with unspecified pathology stating the patient experienced a decrease in platelet count and gastrointestinal bleeding after performing hemodialysis treatments with the device on unspecified dates.Per the hcp, the patient changed to a dialyzer from a different manufacturer and the platelet level improved.The patient continues to perform treatments with the nxstage system one with no further symptoms 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
• MDR Report Key: 11752032
• MDR Text Key: 248158874
• Report Number: 3003464075-2021-00018
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K140526
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other