Alaris, VersaSafe 10807851Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403234446), received between Nov 5, 2019 and Jun 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ VERSASAFE¿ EXTENSION SET EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTION AT THE SPLIT SEPTUM FELL APART DURING AN INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743924 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "ELDERLY MALE WITH PAROXYSMAL ATRIAL FIBRILLATION, HYPERTENSION, AND CHRONIC KIDNEY DISEASE WHO WAS ADMITTED FOR CIRCULATORY SHOCK AND FOUND TO HAVE MSSA BACTEREMIA. PT REPORTED SUDDEN ONSET OF FACIAL SWELLING AND HE ALSO HAD RASHES ON BILATERAL LE, ERYTHEMATOUS SPOTS WHICH ARE NOT RAISED AND NOT ITCHY HIS LEFT ARM WAS SWOLLEN AT THE IV SITE {AT THE SITE OF HIS AMIODARONE INFUSION) AND AMIODARONE TUBING FILTER IS NOTED WITH SIGNIFICANT BROWN SEDIMENT . PT HAS TOLERATED AMIODRONE PREVIOUSLY PRIOR TO SWITCHING TO SOTALOL AFTER 2 MONTHS OF THERAPY CHART NOTES WITHOUT EDITS "PT NOTED INCREASED LIP SWELLING AND SPOTTY MACULAR RASH WHICH SLOWLY IMPROVED THROUGHOUT THE DAY AND IS NEARLY RESOLVED THE NEXT MORNING NO OTHER SWELLING IN THE FACE OR TONGUE NO DIFFICULTY WITH MANAGING SECRETIONS OR DIFFICULTY SPEAKING THE ONLY TWO NEW MEDICATIONS HE TOOK THE DAY BEFORE WERE IMODIUM AND MELATONIN, NEITHER OF WHICH ARE THOUGHT TO BE HIGH RISK FOR HYPERSENSITIVITY AMIO FILTER DID HAVE SOME PARTICULATE MATTER IN IT WORTH MENTIONING THAT HE WAS ON STEROIDS UNTIL 2 DAYS BEFORE, WHICH MAY HAVE BEEN MASKING O

  Patient problems: Rash; Skin Irritation; Swelling

  MAUDE report 9278685 ↗