Alaris, VersaSafe 10779313Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403234279), received between May 9, 2019 and Aug 12, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP BUR 20D 3VS SEPARATED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:1077-9313 BATCH NO: UNKNOWN. IT WAS REPORTED THAT PLASTIC CAP ON TOP OF BURETROL SEPARATED CAUSING CHEMO SPILLS. INITIAL NOTICE: WE RECENTLY BEGAN USING OUR ORIGINAL BURETROLS. WE HAVE SINCE HAD ISSUES WHERE THE PLASTIC CAP AT THE TOP OF THE BURETROL HAS COME OFF. THIS HAS HAPPENED 3 TIMES NOW IN THE LAST PAST 2 WEEKS- ALL RESULTING IN CHEMO SPILLS AND THE NEED TO PREPARE NEW DOSES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395797 ↗
• MalfunctionJun 19, 2020Break; Break

  IT WAS REPORTED THAT A MONTH PRIOR, THE PLASTIC PIECE ON TOP OF BURETTE BROKE OFF. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 10176733 ↗
• MalfunctionJun 15, 2020Break; Break

  IT WAS REPORTED FROM (B)(6) THAT ONE MONTH PRIOR THE PLASTIC PIECE ON TOP OF BURETTE HAD "BROKEN" OFF. CHEMOTHERAPY PRODUCT HAD BEEN PRIMED INTO THE TUBING BY THE PHARMACY TWO HOURS PRIOR TO THERAPY. THE CHEMOTHERAPY AGENT WAS ABOUT TO BE STARTED UNTIL THE PLASTIC PIECE BROKE OFF, SPILLING CHEMO INTO THE BAG THAT IT WAS DELIVERED IN. THIS CAUSED A 30 MINUTE DELAY IN STARTING THERAPY. THE EXPOSURE WAS CONTAINED TO THE BIOHAZARD BAG THAT THE CHEMO WAS DELIVERED IN. CHEMO STARTED APPROXIMATELY THIRTY MINUTES LATE. THERE WAS NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10155020 ↗
• MalfunctionMay 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETROL TUBING SET LEAKED FROM THE TOP IN THE INFUSION CENTER. THE CUSTOMER LATER REPORTED THAT THE TUBING SET WAS NOT ATTACHED TO A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Information

  MAUDE report 8595769 ↗
• MalfunctionMay 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETROL TUBING SET LEAKED FROM THE TOP IN THE INFUSION CENTER. THE CUSTOMER LATER REPORTED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8595768 ↗
• MalfunctionMay 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETROL TUBING SET LEAKED FROM THE TOP IN THE INFUSION CENTER. THE CUSTOMER LATER REPORTED THAT THE TUBING SET WAS NOT ATTACHED TO A PATIENT AT THE TIME OF THE EVENT, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 8595533 ↗
• MalfunctionMay 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETROL TUBING SET LEAKED FROM THE TOP IN THE INFUSION CENTER. THE CUSTOMER LATER REPORTED THAT THE TUBING SET WAS NOT ATTACHED TO A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Information

  MAUDE report 8595371 ↗