Alaris, SmartSite 10927766Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613203019101), received between Aug 28, 2018 and Mar 17, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE IV TUBING SET SEPARATED AND LEAKED. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 9845022 ↗
• MalfunctionJan 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INFUSION OF HEPARIN, THE PATIENT FELL WHILE TAKING A WALK IN THE HALLWAY, THE TUBING LEAKED ABOUT 50CC OF HEPARIN ON THE FLOOR. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592370 ↗
• MalfunctionDec 4, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AT 3:00AM THE RN INITIATED A LABETALOL INFUSION AT A RATE OF 30ML/HR., AND A (VTBI) VOLUME TO BE INFUSED OF 100ML. BETWEEN 3:00AM AND 3:30AM, THE PATIENT CALLED THE RN TO THE ROOM TO REPORT THAT SOMETHING WAS WET ON HIS ARM. UPON OBSERVATION, IT WAS FOUND THAT THE LABETALOL WAS PIGGY BACKED INTO THE IV PORT AND THE WHITE CAP HAD POPPED OFF THE INJECTION PORT, BUT THE BLUE PART REMAINED IN THE TUBING. THE PATIENT BLED APPROXIMATELY 200ML - 300ML OF BLOOD ONTO THE FLOOR. THIS TUBING MALFUNCTION CAUSED AN INTERRUPTION IN THE MEDICATION ADMINISTRATION AND THE PATIENT BLEEDING FROM THE SITE CAUSED A DROP IN HGB BY (1) POINT AS WELL AS THE PATIENT'S BLOOD PRESSURE INCREASED BY (27) POINTS. THIS RESULTED IN INCREASED MONITORING OF THE PATIENT.

  Patient problems: Blood Loss; High Blood Pressure/ Hypertension

  MAUDE report 9410415 ↗
• MalfunctionNov 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN ADMINISTERING ELECTROLYTES, INFUSION SET PULL APART AT THE PUMP SEGMENT. THE NURSE SWITCH OUT THE TUBING WHICH CAUSES DELAY . THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9344662 ↗
• MalfunctionNov 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN ADMINISTERING ELECTROLYTES, THE INFUSION SET PULLS APART AT THE PUMP SEGMENT. THE RN SWITCH OUT THE TUBING WHICH CAUSED A DELAY. ALTHOUGH REQUESTED, THERE HAS BEEN NO FURTHER PATIENT OR EVENT INFORMATION MADE AVAILABLE TO DATE.

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

  MAUDE report 9321496 ↗
• MalfunctionSep 5, 2019Backflow; Backflow

  IT WAS REPORTED THAT TUBING BACKFLOWS INTO PRIMARY. CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT WHICH STATES, "SITUATION, TWO BD ALARIS TM PUMP INFUSION SETS HAVE BEEN CONFIRMED TO HAVE FAULTY BACK CHECK VALVES THE EVENTS WERE IDENTIFIED WHEN PIGGYBACKING A SECONDARY INFUSION INTO THE PRIMARY SET THE SECONDARY BAG RAPIDLY EMPTIED INTO THE PRIMARY DRIP CHAMBER FILLING AND BUBBLING INTO THE PRIMARY BAG THESE TWO EVENTS WERE CAUGHT PRIOR TO REACHING THE PTS FDA SAFETY REPORT ID # (B)(4)."

  Patient problems: No Patient Involvement

  MAUDE report 8967286 ↗
• MalfunctionApr 25, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED AT THE BLUE CONNECTION ABOVE THE PUMP SEGMENT WHILE INFUSING CARDIZEM TO A PATIENT. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8551873 ↗
• MalfunctionAug 28, 2018Material Deformation; Material Deformation

  THE CUSTOMER REPORTED A BULGE IN THE SILICONE SEGMENT OF THE TUBING SHORTLY AFTER STARTING THE INFUSION AND AFTER THE PUMP ALARMED. THE TUBING WAS CONNECTED TO A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824737 ↗