FDA Adverse Event Death Summary report: N

GRANUFLO DRY ACID CONCENTRATE

MDR report key: 6261560 · Received January 17, 2017

Report

Report Number
6261560
Event Type
Death
Date Received
January 17, 2017
Date of Event
December 12, 2016
Report Date
January 11, 2017
Manufacturer
FRESENIUS MEDICAL CARE
Product Code
KPO
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
UT
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON (B)(6) 2016, PT DIALYZED 3 HRS 18 MINUTES OF ORDERED 3 HR 15 MINUTES DIALYSIS TREATMENT. PRE DIALYSIS PULSE 103. DURING TREATMENT, PULSES RANGED FROM 52 82; SBT FROM 110-137; DBP FROM 20-65. POST DIALYSIS VS: SITTING B/P 137/65; STANDING B/P 135/51; PULSE 87 REGULAR; RESP 16; TEMP 97.9; 3.1 KG REMOVED. PRE ASSESSMENT: "TIRED, ORIENTED, SOB, CRACKLES NOTED THROUGHOUT - SAYS JUST IN HER THROAT, SAYS TOOK 12H MEDICINE, DRY COUGH, MILD FACIAL AND BLE EDEMA, GOAL SET TO PULL 3KG AS TOLERATED." IN ADDITION, PULSE WAS DOCUMENTED AT 103 REGULAR, TACHYCARDIA, THREADY, AND PT WAS NOTED TO BE ANXIOUS BUT PLEASANT. POST ASSESSMENT INDICATES PT WAS RESTLESS AND AMBULATED WITHOUT ASSISTANCE, NO UNUSUAL FINDINGS NOTED. PT WAS FOUND DECEASED IN HER HOME ON (B)(6) 2016 WHEN STAFF REQUESTED POLICE TO PERFORM A HEALTH AND WELFARE CHECK AFTER SHE DID NOT ARRIVE TO THE DIALYSIS CLINIC FOR HER SCHEDULED TREATMENT. THE PT WAS FOUND ON THE FLOOR IN HER BEDROOM, DECEASED WITH NO MARKS OR BRUISES ON HER. ON 12/27/2016, IT WAS DISCOVERED THAT GRANUFLO 2.0K WAS BEING DELIVERED TO PATIENTS WITH ORDERS FOR 2.0K DIALYSATE. UPON INVESTIGATION, IT WAS DETERMINED THAT THIS HAD BEEN OCCURRING FROM (B)(6) 2016. ORDERED DIALYSATE FOR THIS PT WAS G2231. THE PT DIALYZED ON G3231 FROM (B)(6) 2016. LOT NUMBERS FOR G3231: (B)(6) - 16HXGF021. (B)(6): 16HXGF021, EXPIRATION DATE: 6/30/2017. ON (B)(6) - 16NXGF002. ADD'L EXPIRATION DATE: 10/31/2017.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
41545 GRANUFLO DRY ACID CONCENTRATE GRANUFLO KPO FRESENIUS MEDICAL CARE G3231 16HXGF021
41546 GRANUFLO DRY ACID CONCENTRATE GRANUFLO KPO FRESENIUS MEDICAL CARE 3.0K
41547 GRANUFLO DRY ACID CONCENTRATE GRANUFLO KPO FRESENIUS MEDICAL CARE 2.25CA

Patients

Seq Age Sex Outcome Treatment
1 Death