A CORONER has deemed the death of a five-year-old girl, who suffered brain damage when just six weeks old after being given prescription baby food containing 124 times the permitted level of magnesium, as a medical accident.
Following a two-day inquest in Galway the parents of Elaine Barrett, from Cloonacauneen, Claregalway, said yesterday they were distressed at having to wait seven years to finally learn what caused their daughter’s death.
Frank and Eileen Barrett criticised the manufacturers of the baby food, B Braun Medical, of Naas Road Industrial Park, Dublin, and the Irish Medicines Board, whom they claimed knew from their own investigations what had happened to their daughter’s brain a week after the food had been administered to her in May 2003, but had never contacted them to explain their findings in the intervening seven years.
In a statement read out after the inquest Eileen Barrett said: “Since this whole ordeal began, all we have ever wanted to know is how and why it happened. We will never get justice for our daughter Elaine, but this inquest gives us the answers we have been trying to get for the last seven years.
“We hope that no other family will ever have to experience what we have gone through.
“We were left in the dark about the circumstances that led to our beautiful daughter, Elaine, being given 120 times the recommended dose of magnesium, with devastating consequences. “We only learned this week that both B Braun Medical Ltd and the Irish Medicines Board had the answers to our questions within a week of the tragedy that changed our lives forever.
“It took Elaine’s death and a coroner’s inquest for us to be told what happened. We ask the question why the Irish Medicines Board were not required to furnish us with the findings of their investigation into the circumstances leading up to and including the manufacture of the Total Parental Nutrition bag supplied by B Braun Medical Ltd and Elaine receiving the contaminated bag.”
The couple added that while they accepted the personal apology of Paul Mullaly, managing director of B Braun Medical was sincere, they felt it was “too little, too late”.
It is understood the couple have reached a settlement with B Braun Medical in recent weeks that has yet to be finalised by the High Court. The inquest heard evidence that an incident had occurred at the B Braun manufacturing plant on May 23rd, 2003, which had caused a computer to temporarily “time out” or freeze as the system was manufacturing a bag of food intended for an adult.
That bag of food was subsequently discarded, but human error and a changeover in staff that morning had caused a standard practice – which would have seen the pipe that still contained some of the adult feed and an adult dose of magnesium being “primed” or flushed out with water before the next bag of food intended for Elaine was manufactured – to not be implemented.
Her batch of food, medicines board senior inspector John Lynch told the inquest yesterday, contained 124 times the permitted dose of magnesium for a premature baby, along with 80 times the permitted dose of zinc.
Mr Lynch said B Braun no longer manufactured paediatric TPN bags, but had been allowed to continue manufacturing adult feeds.
Elaine was born prematurely at just 26 weeks in Holles Street hospital on April 16th, 2003. As she got stronger she was transferred back to Galway on May 9th, 2003, but required at times to be fed intravenously and was given a product called Total Parental Nutrition (TPN). This was manufactured by B Braun Medical. Each bag was manufactured to the individual specifications of each patient following instructions from the patient’s hospital each day. Two bags of TPN had been ordered, but when the first of these was fed to Elaine on May 25th, 2003, she became extremely agitated and her condition deteriorated.
A subsequent brain scan showed Elaine had suffered massive brain tissue damage and she died five years later on October 16th, 2008. Coroner Dr Ciaran McLoughlin said the cause of death was bronchopneumonia due to brain injury with hydrocephalus, due to magnesium poisoning.
“And that is a medical accident – not medical misadventure. A medical accident is where there is no intent. This happened really as a result of an accident,” Dr McLoughlin said.
The coroner recommended that in future the medicines board should contact people who found themselves in similar situations to the Barrett family and not leave them waiting so long for answers.
He said that to prevent this from happening again a system of traceability should be put in place whereby bags of food could be easily traced and their contents recorded.
“Only for the vigilance of paediatric registrar, Dr Rezina Naquib at UHG, the problem with the TPN bags might never have been discovered as they could easily have been discarded once administered. This is a very, very rare condition which doctors would not normally see, so it’s important that some record should be available to quantify or qualify what each bag contains. A prescription which is made specifically for an individual – we should have some way of checking its content for that individual.”
The coroner said two similar cases had been reported in a paediatric medical journal in the United States, but only two months after baby Elaine’s experience. He suggested to Mr Lynch that the medicines board should investigate those cases to ensure that this never happened again.
“We need to have a system put in place which satisfies the public, parents and hospital staff that this does not happen again,” he said.