Deaths of two children spark ‘urgent’ investigations at leading trust

Great Ormond Street Hospital Foundation Trust has been investigating the incidents which happened between December 2020 and April 2021. The trust has linked the incidents partly to what it described as a “faulty” batch of a type of glue used to close wounds during surgery.

The glue, called Histoacryl, is produced by B. Braun Medical Ltd, and the company issued three separate “field safety notices”, relating to different batches of the product, in March and April this year.

The company has stressed that it followed the correct recall processes throughout.

According to a report to GOSH’s public board meeting on 29 September, Histoacryl has been used for the endovascular treatment of brain arteriovenous malformations for more than 30 years, but earlier this year batches of the product were identified as hardening less rapidly than expected.

The trust told HSJ in a statement: “A comprehensive serious incident investigation has been carried out to determine the impact of the faulty glue on all patients treated with it.

“The investigation found that whilst the passage of glue through the intended vessel may have been contributory in some instances of harm, it was unlikely to be the sole or main factor.

“Both patients who died had serious and complex medical conditions and the procedure to correct these always carries a high degree of risk which is discussed extensively with the families before any treatment takes place.”

The trust’s initial investigations found it had no formal policy in place to receive and manage field safety notices, which are used by suppliers to alert customers to faulty products.

For example, GOSH’s board papers said clear guidance was needed within the trust for how alerts should be distributed and what action should be taken once an alert is received. The papers warned a “lack of clear governance [at the trust]… poses a risk to patients and needs to be urgently addressed”.

However, GOSH also said it did not receive an alert for the specific batches of the glue it had received through NHS Supply Chain until late April.

The first alert from manufacturer B. Braun was issued in early March. The trust said it received this first alert from “a competitor”, and not directly from B. Braun, but said that the alert related to a limited number of batches of the glue, and not those it had received.

Another alert was issued by the company in mid-March, but this related to further batches of the product which had not been received by GOSH.

The third alert, which did relate to the batches received by GOSH, was issued in late April, and the trust said its procurement team was contacted directly by the company at this stage.

According to the trust’s board reports, one of the patients on whom an affected batch was used died in March, although a specific date was not stated.

In a statement, B.Braun said it notified customers who received affected batches of Histoacryl via “three separate field safety notices on the 9 March 2021, 17 March 2021 and 29 April 2021”.

The company has said: “GOSH received the products from NHS Supply Chain who only purchased products with the batch numbers which were recalled in the third field safety notice on the 29 April 2021.”

A spokeswoman said the company “followed the correct recall process” and could not make further comment as a coroner’s inquest is underway.

NHS Supply Chain has said in a statement: “The field safety notices in March 2021 did not include any lot numbers supplied to NHS Supply Chain.”

B. Braun and NHSSC said they could not confirm which other NHS trusts received the affected batches.