NXSTAGE SYSTEM ONE CAR-172

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-20 for NXSTAGE SYSTEM ONE CAR-172 manufactured by Nxstage Medical, Inc..

Event Text Entries

[188244659] There was no indication of a device malfunction. All devices must meet quality requirements and manufacturing specifications prior to release. Bio-compatibility has been established. The instructions for use warns that the device must be used under the prescription of a physician. The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.
Patient Sequence No: 1, Text Type: N, H10


[188244660] A report was received on 22 feb 2020 from a healthcare professional regarding an adult with end stage renal disease who experienced a platelet decrease after using the nxstage device, dates not provided. The patient's kidney transplant surgery was delayed due to the reported issue on an unspecified date, approximately two months earlier, prior to the date the report was received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003464075-2020-00019
MDR Report Key9861227
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-01-01
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-22
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. PAULA ROGALSKI
Manufacturer StreetNXSTAGE MEDICAL, INC 350 MERRIMACK STREET
Manufacturer CityLAWRENCE MA 01843
Manufacturer CountryUS
Manufacturer Postal01843
Manufacturer Phone9784505276
Manufacturer G1MEDIMEXICO S. DE R. L. DE C. V
Manufacturer StreetAV. VALLE IMPERIAL NO. 10523 PARQUE INDUSTRIAL VALLE SUR
Manufacturer CityTIJUANA 22180
Manufacturer CountryMX
Manufacturer Postal Code22180
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameNXSTAGE SYSTEM ONE
Generic NameHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Product CodeKDI
Date Received2020-03-20
Model NumberCAR-172
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerNXSTAGE MEDICAL, INC.
Manufacturer Address350 MERRIMACK STREET LAWRENCE MA 01843 US 01843

Device Sequence Number: 101

Brand NameACETAMINOPHEN 500MG
Product Code---
Date Received2020-03-20
Device Sequence No101
Device Event Key0
ManufacturerMANUFACTURE / COMPOUNDER NAME


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.