FDA Adverse Event Death Summary report: N

BECKMAN ELUTRIATOR

MDR report key: 254785 · Received December 17, 1999

Report

Report Number
MW1017753
Event Type
Death
Date Received
December 17, 1999
Date of Event
December 15, 1999
Report Date
December 17, 1999
Manufacturer
BECKMAN COULTER, INC.
Product Code
GKT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

FAILURE TO ENGRAFT. THE PT UNDERWENT A BONE MARROW TRANSPLANTATION FROM A MATCHED UNRELATED DONOR IN 1999. PER PROTOCOL, THE PT RECEIVED BUSULFAN AND CYCLOPHOSPHAMIDE AS THE CHEMOTHERAPY PREPARATIVE REGIMEN, FOLLOWED BY THE IMMUNOSUPPRESSIVE THERAPY OF CYCLOSPORINE A AND METHYLPREDNISOLONE. THE GRAFT COMPOSITION OF CD34 WAS WITHIN NORMAL LIMITS. ALTHOUGH THE PT DID NOT HAVE ANY SIGNIFICANT POSITIVE CULTURES NOTED, A CT SCAN ON 11/26/99 SHOWED "DIFFUSE PATCHY INFILTRATES, INFILTRATES THAT ARE ILL DEFINED AND SUGGEST A FUNGAL ETIOLOGY." THE PT REQUIRED MECHANICAL VENTILATION ON 11/27/99. ON DAY 26 POST TRANSPLANT, DECEMBER 14TH, A BONE MARROW BIOPSY WAS DONE. THE RESULTS SHOWED "VIRTUALLY ACELLULAR MARROW WITH FIBROBLASTS, LYMPHOCYTES, HISTIOCYTES, AND VERY RARE HEMATOPOIETIC PROGENITOR CELLS." A DECISION TO WITHDRAW CARE WAS MADE SECONDARY TO PROGRESSING RESPIRATORY SYMPTOMS WITH A PULMONARY HEMORRHAGE, MULTI-ORGAN FAILURE, AND GRAFT FAILURE. THE PT EXPIRED 27 DAYS POST TRANSPLANT. GRAFT FAILURE IS A WELL-KNOWN COMPLICATION OF BONE MARROW TRANSPLANTATION FROM UNRELATED DONORS. THE PRECISE ETIOLOGY OF SUCH GRAFT FAILURES IS UNCLEAR. ONE KNOWN RISK FACTOR IS THE MISMATCH AT HLA-C, WHICH WAS NOT THE CASE IN THIS PT. THERE HAVE BEEN TWO GRAFT FAILURES IN THE FIRST SEVENTEEN PTS ON THIS PROTOCOL (11%), WHICH IS THE INCIDENCE OF GRAFT FAILURE COMMONLY SEEN IN THIS SETTING NATIONALLY. THIS RISK FACTOR IS STATED IN THE CURRENT CONSENT FORM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BECKMAN ELUTRIATOR ELUTRIATOR GKT BECKMAN COULTER, INC. J6M *

Patients

Seq Age Sex Outcome Treatment
1 34 YR Death| L| R