FDA Adverse Event Death Summary report: N

ROSS

MDR report key: 402525 · Received June 26, 2002

Report

Report Number
MW1025420
Event Type
Death
Date Received
June 26, 2002
Date of Event
March 1, 2001
Report Date
June 20, 2002
Manufacturer
ROSS PRODUCTS DIV. ABBOTT LABORATORIES INC.
Product Code
FPD
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT'S SKIN AND SCLERA TURNED GREEN BEFORE DEATH. URINE INCREASINGLY GREEN 2001 X 5 DAYS. CT DRAINAGE TINGED GREEN, STOOLS GREEN FOR 2 DAYS. PT ON TUBE FEEDINGS FOR 9 DAYS. JEVITY PLUS 20-50 CC/HR. FORMULA CHANGED ON DAY 7 PULMOCARE. FIVE DAYS PRIOR, PNEUMOTHORAX QUESTION OF ILEUS ON DAY 7. QUESTION OF GI OBSTRUCTION 3 DAYS LATER. 2 DAYS EARLIER EXTUBATED. STARTED TPN. AUTOPSY FINDINGS INCLUDE: ACUTE MI, CARDIO RESP FAILURE, POSSIBLE SEPTICEMIA, FATTY LIVER, ISCHEMIC COLITIS WITH MARKED DILATION OF CECUM AND COLON. PERITONEAL CAVITY CONTAINED 600 CC BLUE STAINED FLUID. PLEURAL SURFACE: SMALL AMOUNT ANTHRACOTIC PIGMENT. PT ON AMIODERONE IN 2001 ONE DAY AFTER START OF TUBE FEEDINGS. PT ON SOLUMEDROL. PT COMPLAINED OF SEVERE WEAKNESS 20 DAYS LATER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ROSS COLORMARK TUBING (BLUE DYE) FPD ROSS PRODUCTS DIV. ABBOTT LABORATORIES INC. * *

Patients

Seq Age Sex Outcome Treatment
1 68 YR Death