FDA Adverse Event Death Summary report: N

NXSTAGE

MDR report key: 653575 · Received September 19, 2005

Report

Report Number: MW1036659
Event Type: Death
Date Received: September 19, 2005
Date of Event: September 15, 2005
Report Date: September 19, 2005
Manufacturer: NXSTAGE MEDICAL INC.
Product Code: KDI
Adverse Event: Yes
Report Source: Voluntary report
Reporter Location: CA, US
Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

PT WAS USING THE NXSTAGE SYSTEM ONE HOME HEMODIALYSIS UNIT. SHE WAS HEAVILY MEDICATED FOR A VERY BAD MIGRAINE HEADACHE AND WAS USING THE MACHINE WHILE ALONE. SHE WAS SPECIFICALLY INSTRUCTED NOT TO USE THE MACHINE WHILE ALONE. SHE COULD HAVE BEEN VERY CONFUSED OR DELUSIONAL BY THE HEADACHE MEDICATION. SHE CONNECTED HERSELF TO THE MACHINE AS SHE WOULD NORMALLY DO. SHE EVEN SET OUT SUPPLIES FOR HER PARTNER. SHE FILLED OUT THE FORM AS SHE WOULD NORMALLY DO. THE START TIME WAS LISTED AS 2:26 AM. THIS WAS UNUSUAL. SHE NORMALLY HAS HER TREATMENTS IN THE MID MORNING OR THE EARLY AFTERNOON. RPTR'S SPOUSE AND FAMILY MEMBER ARE PT'S NORMAL PARTNERS. SHE ALSO HAS A FRIEND THAT IS TRAINED AS WELL TO BE HER PARTNER ON AN OCCASIONAL BASIS. SHE STARTED HER TREATMENT AND FILLED OUT THE FIRST ROW OF DATA ON THE FORM. IT IS UNCLEAR TO US WHAT EXACTLY AT THAT POINT WENT WRONG. RPTR HAS ALSO CONSIDERED THAT THIS DEATH COULD HAVE BEEN COINCIDENTAL BUT RPTR FEEL THAT THIS IS UNLIKELY. THE END RESULT IS THAT WHEN RPTR WAS UNABLE TO REACH HER IN THE MORNING THEY BECAME CONCERNED AND CALLED THE BUILDING MANAGER TO OPEN HER APARTMENT. SHE WAS FOUND DEAD ON THE FLOOR STILL CONNECTED TO HER MACHINE. THE CORONER REMOVED HER BODY. AN AUTOPSY HAS BEEN PERFORMED. RPTR IS WAITING FOR THE RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NXSTAGE	HOME HEMODIALYSIS MACHINE	KDI	NXSTAGE MEDICAL INC.	SYSTEM ONE	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Death