Powdered baby formula linked to patient death

Implicated batch recalled


A commercial powdered baby formula used for neonate patients has been linked to a fatal meningitis infection due to Enterobacter sakazakii, the Centers for Disease Control and Prevention (CDC) reports. The batch of Portagen implicated in this investigation (coded BMC17) was recalled voluntarily by Mead Johnson Nutritionals on March 29, 2002. In April 2001, a male infant (2 lbs., 13 oz.) was delivered by cesarean at 33.5 weeks’ gestation and was hospitalized in a neonatal intensive care unit (NICU) because of low birth weight, prematurity, and respiratory distress. The infant developed meningitis and died nine days later. An investigation ensued because the implicated pathogen is a rare cause of neonatal meningitis.

The CDC tried to determine if other infants in the NICU were either infected or colonized with E. sakazakii. Patients were assessed for colonization by stool culture, and microbiology laboratory records were reviewed for reports of E. sakazakii. A total of 49 infants were screened. A total of 10 E. sakazakii infection or colonization events were identified: one confirmed infection in the index patient, two suspected infections, and seven colonizations. One patient was colonized at two sites (urine and stool).

Analysis of risk factors identified only use of Portagen to be significantly associated with E. sakazakii infection or colonization. All case-patients received Portagen compared with 21 of 40 noncase-patients.

Cultures of formula taken from both opened and unopened cans of Portagen from a single batch grew E. sakazakii. Water and all environmental cultures were negative. Pulsed-field gel electrophoresis revealed that isolates of E. sakazakii from the index case were indistinguishable from the cultures found in opened and unopened formula containers.

Hospital personnel reviewed NICU infection control practices, policies, and procedures for preparation, storage, and administration of powdered infant formula. No breaches in infection control were detected. The product was prepared in the NICU according to manufacturer’s instructions. Powdered formula was mixed with sterile water and was immediately refrigerated and used within 24 hours of preparation. The infant with E. sakazakii meningitis was given formula by continuous administration; administration time did not exceed eight hours. Clinicians should be aware that powdered formulas are not sterile products and might contain opportunistic bacterial pathogens such as those in the family Enterobacteriacae, including E. sakazakii, the CDC warned. These products commonly are used at many hospitals.

A recent survey indicated that of 16 responding facilities, nine used powdered formulas in the NICU setting; four (25%) reported powdered formula as a principal source of patient feeding, and five (31%) reported use of powdered formula along with other formula types for principal feeding.

Patient risk for infection could depend on several factors, including the number of bacteria present in the product, handling after preparation, and underlying patient characteristics such as immunosuppression, prematurity, or low birth weight.

To prevent more infections, the CDC advises:

  • Formula products should be selected based on nutritional needs; alternatives to powdered forms should be chosen when possible.
  • Trained personnel should prepare powdered formula under aseptic technique in a designated preparation room.
  • Manufacturer’s instructions should be followed; product should be refrigerated immediately and discarded if not used within 24 hours after preparation.
  • The administration or "hang" time for continuous enteral feeding should not exceed four hours.
  • Written hospital guidelines should be avail-able in the event of a manufacturer product recall, including notification of health care providers, a system for reporting and follow-up of specific formula products used, and retention of recall records.


1. Centers for Disease Control and Prevention. Enterobacter sakazakii infections associated with the use of powdered infant formula — Tennessee, 2001. MMWR 2002; 51:298-300.