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 Ltd, 3 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 Mrs 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 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 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 a settlement with B Braun was reached in recent weeks which has yet to be finalised by the High Court.
The inquest heard evidence that an incident had occurred at the manufacturing plant on May 23, 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, during which the pipe which still contained some of the adult feed, which in turn contained an adult dose of magnesium, had not been “primed” or flushed out with water prior to the next bag of food intended for baby Elaine being manufactured.
Irish Medicines Board senior inspector John Lynch said the company no longer manufactures paediatric TPN bags but has been allowed to continue manufacturing adult feeds.
Baby Elaine was born prematurely at just 26 weeks in Holles Street Hospital on April 16, 2003.
As she got stronger she was transferred back to Galway on May 9, 2003, but required at times to be fed intravenously and was given a product called Total Parental Nutrition (TPN).
Two bags of TPN had been ordered but when the first of these was fed to Elaine on Sunday, May 25, 2003, she became extremely agitated and her condition deteriorated.
Doctors in Galway told the couple the following day that high levels of magnesium had been found in Elaine’s blood, having come from the TPN bag supplied by B Braun.
A subsequent brain scan showed Elaine had suffered massive brain tissue damage and she died five years later on October 16, 2008.
Coroner Dr Ciarán McLoughlin said a medical accident is where there is no intent. “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.”
The coroner said two similar cases were 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 IMB should investigate those cases to ensure that this never happens 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.
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