Incorrect blood grouping at birth issue at Cavan General

An issue whereby babies may have been incorrectly blood grouped at birth due to a mislabelling error on a blood test kit has arisen at Cavan General Hospital and four other maternity hospitals around the country.

It has been reported that around 540 patients across the country, mothers and their babies have since been notified by the hospitals that there is a small chance their newborn may have been incorrectly blood grouped at time of birth.

The issue arose at Cavan General, Sligo General, Limerick and Galway and at the Rotunda Hospital in Dublin, one of the biggest hospitals in the country, where it is said the majority of the mislabelling concerns were identified.

As part of routine hospital procedures, a baby’s blood group is checked at the time of delivery. The test kit involved is the ORTHO BioVue System Cassette.

The HSE says it was recently notified by the Irish Medicines Board that a Field Safety Notice had been issued by Ortho Clinical Diagnostics, a Johnson & Johnson company, that a small number of the testing kits supplied worldwide have been incorrectly labelled.

The hospitals began contacting affected mothers at the beginning of this week, Monday last. Letters were sent to anyone potentially affected by the manufacturing error though the HSE has moved to play down concern.

In a statement to The Anglo-Celt a HSE spokesperson said: 'The risk of a baby’s blood group test result being incorrect is extremely low as the manufacturing error related to a label being incorrectly affixed to the test kit.'

The manufacturer has estimated that the potential risk of a kit being labelled incorrectly is less than 1 in 11 million.

'There are no immediate safety concerns', the HSE have said, 'however anyone affected can discuss the implications for them directly with their hospital. Each hospital has in place a dedicated phoneline for those affected - contact details have been provided in the letters sent to those affected or are available from the HSE Information line 1850 24 1850'

GPs in areas affected have also being notified of the potential error.

There are four groups of patients potentially affected:

- Mothers who may have required an anti-D injection but did not receive it (30 cases total, 8 in Cavan)

- Mothers who may have received anti-D when they did not need it (220 cases total, 33 in Cavan).

- Babies who received a red blood cell transfusion when they may not have needed it (12 cases total, 0 in Cavan).

- And babies whose blood group result may have been reported incorrectly (278 cases total, 22 in Cavan).

All hospitals involved have since completed an inspection of the remaining kits in stock and have removed any potentially affected stock.

'Every hospital who used these type of kits has completed an inspection of the remaining kits in stock and has removed any potentially affected batches. Each hospital has also conducted a review of the results of the testing done using these kits in each hospital', the HSE statement said.

Meanwhile the HSE says all patients, including babies, have repeat blood group tests carried out when being admitted to any hospital or in pregnancy, but if any mothers wish to have their babies blood test re-checked this can now be done.