Blood service sues over testing device
The German manufacturer of the Haemospect device disputes any defects and claims any inaccurate readings are a result of misuse of it, its counsel told the Commercial Court.
The IBTS case is against MBR Optical Systems GMBH & Co KG, (MBR), Wuppertal, Germany, as manufacturer of the device, and Linc Medical Systems, Leicester, UK, as supplier of a number of the devices to the IBTS.
The IBTS claims the device, which does pre-donation non-invasive finger pulp tests on prospective blood donors before donations are accepted, had falsely recorded hemoglobin levels as within the acceptable range when they were not.
In court files, the IBTS said it began using the device in 2014 and MBR released a software update for it a year later. For reasons including there being no apparent issue in relation to use of the device, and no documented risk assessment in relation to updated software, the IBTS said it decided not to update the software.
The service claims it first became aware of alleged defects after the device recorded a reading allowing a second-time donor proceed with donating blood on October 1, 2015. She became progressively more unwell, developed chest pain and breathlessness and, a week after giving blood, was hospitalised and transfused with two units of blood.
The service suspended use of the device from October 21, 2015.
The IBTS said MBR had initiated an investigation and in December 2015 issued an urgent field safety notice concerning actions it was taking concerning the device and advising it was working on a contemporary solution, a potential software update.
The IBTS claims it bought 20 of the devices from Linc between June 2013 and May 2015 for about €215,532 and also entered a rental agreements with Linc for five devices at a cost of €25,500.
It alleges it has suffered special damages of over €1m on grounds including alleged breach of contract and reputational damage. It is also claiming for some €71,000 legal fees incurred to date.
At the Commercial Court yesterday, Rossa Fanning, for the IBTS, said there was consent to it being entered into the court’s list with hearing directions adjourned arising from possible issues about the jurisdiction of Irish courts to deal with it. He was satisfied Irish courts have such jurisdiction, counsel said.
BMR had last September initiated proceedings in Germany seeking a declaration it is not liable to the IBTS concerning the device, the court heard. Linc wants to consider jurisdictional issues and possible mediation and says there is also an issue concerning the terms of the contracts between the parties, it was stated.
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