Investigation into Maternal Deaths in Ballari Points to Substandard Ringer Lactate Solution Use

The Karnataka Health Department has raised concerns over recent maternal deaths in Ballari, suspecting substandard ringer lactate solution as the cause. This solution, used intravenously to maintain hydration and fluid balance, was supplied by Paschim Banga Pharmaceutical Ltd to the Karnataka State Medical Supplies Corporation Ltd (KSMSCL). The deaths occurred between November 9 and 11 following caesarean operations at the district hospital.

During this period, 34 caesarean operations were conducted, with seven cases developing complications. The health department reported that of these seven patients, four succumbed to issues such as acute kidney injury requiring haemodialysis and multi-organ dysfunction. Two patients have been discharged, while one remains under care at Vijayanagar Institute of Medical Sciences (VIMS), Ballari.

Investigation and Findings

A confidential review was conducted by a team of specialist doctors from Rajiv Gandhi University of Health Sciences. This review was initiated by the principal secretary of health and Family Welfare. The report concluded that there was no negligence or dereliction of duty by the medical team at District Hospital, Ballari.

The officials highlighted that all necessary protocols for patient care, caesarean procedures, complication recognition, and management were followed satisfactorily. Despite the efforts in the post-operative ward, ICU, and dialysis unit at both the District Hospital and VIMS Ballari, four patients could not be saved.

Quality Concerns and Actions Taken

The complications are suspected to be linked to the ringer lactate solution provided by Paschim Banga Pharmaceutical Ltd. KSMSCL had previously frozen all 192 batches supplied by this company. On March 18, 2024, two batches were deemed substandard by the Drugs Control Department.

However, after receiving a certificate of standard quality from Central Drug Laboratories, KSMSCL allowed the use of 84 batches on August 13, 2024. Currently, the batch in question has been withdrawn statewide, and samples from Ballari district hospital have been sent for testing.

The investigation continues to ensure patient safety and prevent future incidents. The health department is committed to addressing any issues related to medical supplies and maintaining high standards in healthcare delivery across Karnataka.