Substandard lactate solution may have caused Ballari deaths: K'taka govt

Karnataka Health Department on Friday said the recent maternal deaths in Ballari are suspected to be due to the use of substandard ringer lactate solution that is administered intravenously to restore hydration and fluid balance in the body.

According to a statement, the solution was supplied by Paschim Banga Pharmaceutical Ltd to Karnataka State Medical Supplies Corporation Ltd.

The health department's officials said a sudden spurt in maternal deaths was reported from the Ballari district hospital between November 9 and 11. The deaths were reported to have occurred following caesarean operations at the hospital.

Of the 34 caesarean operations performed in those three days, seven cases developed complications.

In a statement, the health department said that out of the seven patients who developed complications such as acute kidney injury requiring haemodialysis and multi-organ dysfunction, four died.

Two have been discharged from the hospital and one patient is recovering at Vijayanagar Institute of Medical Sciences (VIMS), Ballari, it stated.

"There was a confidential review of the maternal deaths conducted by a team of specialists doctors constituted by the Rajiv Gandhi University of Health Sciences at the behest of the principal secretary of health and Family Welfare.

"On perusal of the report, it is evident that there has been no negligence or dereliction of duty by the team at District Hospital, Ballari," the statement said.

Citing the report, the officials said necessary protocols and guidelines for patient care, caesarean section procedure, recognition of complications and management were satisfactorily performed.

Despite the best team effort at the post-operative ward, ICU and dialysis unit of the District Hospital and VIMS Ballari, four patients could not be saved, they said.

"The onset of complications following caesarean operations is being suspected to the ringer lactate solution supplied by Paschim Banga Pharmaceutical Ltd to Karnataka State Medical Supplies Corporation Ltd (KSMSCL). Earlier, all 192 batches supplied by the said company were temporarily frozen by KSMSCL, even though two batches were declared not of standard quality on March 18, 2024, by the Drugs Control Department," a statement said.

"Later, following the certificate of standard quality by Central Drug Laboratories, the usage of ringer lactate of 84 batches was permitted by  KSMSCL on August 13, 2024," it said.

The statement added that currently, the ringer lactate solution batch has been withdrawn across the State and the fluids supplied to the Ballari district hospital have been sent for testing.