ESP 80A AEROBIC BROTH

Description of Event or Problem

THE FOLLOWING INFO WAS PROVIDED BY THE ATTENDING NEONATOLOGIST AND OTHER HOSP PERSONNEL: A PREMATURE INFANT (30-31 WEEKS GESTATION) WAS DELIVERED BY CAESARIAN ON 08/29/98. DURING THE EFFORTS TO RESUSCITATE THE INFANT, A PHYSICIAN REQUESTED AN INJECTION OF ALBUMIN. HOWEVER, INSTEAD OF ALBUMIN, 5-10 CC OF AN IN VITRO DIAGNOSTIC PRODUCT INTENDED FOR DETECTION OF SEPTICEMIA WAS INJECTED INSTEAD. THE INFANT DIED ONE DAY LATER ON 08/30/98. THE ATTENDING NEONATOLOGIST STATED THAT HE DID NOT BELIEVE THAT THE INJECTION ERROR WAS THE CAUSE OF DEATH SINCE THE INFANT HAD SIGNIFICANT OTHER MEDICAL PROBLEMS INCLUDING EARLY DELIVERY, FETAL TO MATERNAL HEMORRHAGING, AND PULMONARY HYPOTENSION. AS OF 09/22/98, THE MEDICAL EXAMINER WAS STILL EVALUATING THE CASE. THE PRODUCT THAT WAS INJECTED BY MISTAKE WAS A MICROBIOLOGICAL CULTURE MEDIUM INTENDED FOR THE DETECTION OF SEPTICEMIA. IT IS LABELED AS AN IN VITRO DIAGNOSTIC PRODUCT AND IS NOT INTENDED FOR ANY OTHER USE. BASED ON ALL INFO TO DATE, THERE IS NO EVIDENCE THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE INFANT'S DEATH AND IT IS CLEAR THAT THE PRODUCT WAS USED IN A MANNER FOR WHICH IT WAS NEVER INTENDED.