BD Alaris 8015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403517921), received between May 28, 2024 and May 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Operating System Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2024Device Alarm System; Computer Operating System Problem; Device Alarm System; Computer Operating System Problem

  IT WAS REPORTED THAT THE PC UNIT (SOFTWARE VERSION 12.3.1.2) HAD A SYSTEM ERROR (ERROR CODE 9-1513-202) DURING SIMULATION TESTING. THE USER WAS INITIALLY ATTEMPTED TO RECREATE AN ISSUE ¿WITHOUT A MAX IN THE PCA AND THEN ADDING IT IN AFTER THE INFUSION STARTED¿ AND THE USER WAS UNABLE TO RECREATE A SYSTEM ERROR AT THAT TIME¿. A FEW HOURS LATER, THE USER STATED THAT THE DEVICE ¿SUDDENLY GOT A SYSTEM ERROR¿. THE USER WAS UNABLE TO SILENCE THE ALARM. NONE OF THE MODULES WERE INFUSING AT THE TIME. THE PROGRAMMING THAT THE USER WAS DOING WAS ¿KETAMINE GREATER THAN 45KG CONCENTRATION 500MG/50ML PCA DOSE 10 MG LOCKOUT INTERVAL 15 MINUTES AND CONTINUOUS DOSE 15MG/HR. NO MAX AND THEN START AND ONCE STARTED WENT BACK AND ADDED A MAX¿. THE USER REPORTEDLY INITIALLY DID THIS SEVERAL TIMES WITHOUT AN ERROR. AS PREVIOUSLY STATED, A FEW HOURS LATER, WHILE SITTING IN STANDBY WITH DEVICE TURNED ON WITHOUT AN INFUSION RUNNING, IT WENT INTO SYSTEM ERROR. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED IN A TEST ENVIRONMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402558 ↗