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

• Five serious incidents, including the deaths of two children, spark “urgent” investigations at specialist trust
• Great Ormond Street Hospital FT has linked the incidents partly to what it described as a “faulty” batch of a type of glue used to close wounds during surgery
• Supplier says it followed the correct recall processes for the product

Five serious incidents, including the deaths of two children, have sparked ‘urgent’ investigations into the processes through which clinicians are alerted to potential safety concerns over medical products used on patients.

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.”

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Original source: Health Service Journal