December 19, 2003

Statement From Johns Hopkins Medicine Regarding The Death Of Brianna Cohen

With permission from the family given December 17, Johns Hopkins can now, and with deep regret, sadness and apology, publicly report and take responsibility for the untimely death December 4, 2003 of Brianna Cohen, 2, the child of Mark and Mindell Cohen of Owings Mills, Maryland.

What Happened

Brianna was, at the time of death a child with cancer followed by the staff at the Johns Hopkins Childrens Center. She was being treated at home with Total Parenteral Nutrition (TPN) through intravenous infusion services provided by Pediatrics at Home, a subsidiary of The Johns Hopkins Home Care Group, when her parents found her unresponsive and took her immediately to the nearest community hospital, where she was pronounced dead. The TPN infusion bag was prepared by the infusion pharmacy of Johns Hopkins Home Care, which is jointly owned by The Johns Hopkins Health System and Johns Hopkins University.

Tests conducted immediately thereafter showed that the TPN solution bag in use at the time of death contained excessively high levels of potassium. Although our analysis is incomplete, and we are as yet unable to recreate the precise series of events that occurred, Hopkins fully accepts that the most likely explanation for this tragic event is that human error in the manual formulation of the solutions at the Home Care pharmacy led to excess levels of potassium in the TPN bag. At the family's request no autopsy was performed.

Hopkins Accepts Responsibility

Hopkins not only accepts full responsibility, but also continues to fully cooperate with the family in its quest for information, notified relevant regulatory agencies, and immediately put in place substantive measures to assure that all current and future TPN preparations given to patients are safe.

New Safety Measures

Among those measures, preparation of all Home Care TPN solutions, for both children and adults, has been assigned to fully automated systems now used for Hopkins inpatients until further notice. Home Care will not resume any manual preparation, but will automate its systems as well.

Beginning December 11, all pediatric TPN infusions have been formulated by the inpatient pharmacy at Johns Hopkins and no further TPN solutions are being prepared at Pediatrics at Home pharmacies. The Johns Hopkins Hospital Pediatric Infusion Pharmacy (JHHPIP), using automated rather than manual mixing procedures, reformulated all-new TPN preparations, which were distributed by Pediatrics at Home to current home-care pediatric TPN patients. All TPN solutions delivered prior to that day were replaced.

As an extra precaution, all remaining TPN bags for adults delivered up to that time were retrieved and replaced as well. And on December 12, Johns Hopkins Pharmaquip's home infusion pharmacy service, was asked to provide all adult TPN formulation services through the automated Compounding Admixture Pharmacy Services (CAPS) program used by The Johns Hopkins Hospital and most area hospitals. All adult TPN patients were switched to CAPS on December 13 and December 14. These changes should cause no disruption for patients.

What is TPN?

TPN provides a solution containing all the required nutrients including protein, fat, calories, vitamins and minerals, infused over several hours into a vein, through a catheter. TPN provides a complete and balanced set of nutrients for patients who cannot consume a normal diet, including cancer patients.

JHM's Commitment to Patient Safety

As the recent series in The Sun explored in depth, Johns Hopkins Medicine has a deep and lengthy commitment to identifying patient safety risks; to making extraordinary resources -- both human and financial -- available to reduce those risks to the absolute minimum; and to working with families who have helped us turn their personal tragedies into safer care for others. All of us at Hopkins offer the Cohen family our deepest condolences and a pledge to do whatever it takes to prevent a similar occurrence and to appropriately honor their daughter's memory.