Alaris, SmartSite 10933805Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613203019088), received between Dec 20, 2018 and Apr 3, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET LEAKED NORMAL SALINE UNDER THE DRIP CHAMBER BEFORE USE. IT WAS REPORTED THAT THIS OCCURRED IN A CHEMO OUTPATIENT DEPARTMENT, 7N. THERE WAS NO PATIENT INVOLVEMENT .

  Patient problems: No Patient Involvement

  MAUDE report 9924811 ↗
• MalfunctionNov 8, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CHEMOTHERAPY (CYTARABINE) INFUSION, THE PRIMARY TUBING LINE WAS CRACKED, WHICH CAUSED LEAKING. THE CLINICIAN REPORTED THE LEAK TO BE APPROXIMATELY 50CC. THE PATIENT WAS EXPOSED TO THE LEAKED (CYTARABINE), THAT WAS ON THE FLOOR WHEN SHE STEPPED IN IT UNKNOWINGLY WITH HER FOOT. THE THERAPY WAS DELAYED APPROXIMATELY (1.5) HOURS DUE TO RE-MIXING. ALTHOUGH, IT WAS REPORTED THAT PATIENT CARE WAS DELAYED, IT DID NOT CONTRIBUTE TO, OR RESULT IN ANY SERIOUS ADVERSE IMPACT TO PATIENT OR TO THE CAREGIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297161 ↗
• MalfunctionOct 28, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "INTRAVENOUS (IV) PUMP ALARMING OCCLUDED ON PATIENT SIDE, WHEN RULED OUT OCCLUSION FROM PATIENT AND REMAINS TO ALARM, IV PUMP OPENED NOTED TUBING M PUMP FORMING BALLOON BELOW BLUE PORTION OF PRIMARY TUBING AND RUPTURED/BROKE." IT WAS NOTED THAT IV POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.9% SODIUM CHLORIDE WAS INFUSING AT THE TIME OF THE EVENT. IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246788 ↗
• MalfunctionOct 28, 2019Stretched; Stretched

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NOTED AIR IN LINE ALARM FOLLOWED BY SAFETY CLAMP ALARM NOTED BALLOONING BELOW FIRST BLUE PART WHERE THE TUBING LOCKS INTO THE PUMP." AN INCOMPLETE EVENT DATE OF (B)(6) 2019 WAS PROVIDED. THE EVENT OCCURRED IN THE PEDIATRIC ICU (PICU). IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246116 ↗
• MalfunctionOct 22, 2019Material Separation; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "ALARIS PUMP INFUSION SET REMOVED FROM PACKAGING AND NOTED TO BE IN TWO PIECES." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. IT WAS REPORTED THAT THERE WAS NO DELAY IN PATIENT THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 9221564 ↗
• MalfunctionOct 16, 2019Failure to Prime; Failure to Prime

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "INTRAVENOUS TUBING WOULD NOT PRIME." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. IT WAS REPORTED THAT THE EVENT OCCURRED IN PEDIATRIC ICU (PICU). THERE WAS NO DELAY IN PATIENT THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 9200375 ↗
• MalfunctionSep 19, 2019Stretched; Stretched

  IT WAS REPORTED THAT THE IV INFUSION PUMP WAS ALARMING WHILE INFUSING 1 LITER OF NORMAL SALINE AT 500ML/HR PRIOR TO A CHEMOTHERAPY INFUSION. THE NURSE WAS UNABLE TO RECALL THE DEVICE'S EXACT ONSCREEN ALARM MESSAGE, BUT STATES IT WAS EITHER "OCCLUSION" OR "AIR-IN-LINE". WHEN THE NURSE OPENED THE DEVICE'S DOOR, IT WAS FOUND THAT A BUBBLE HAS FORMED ON THE TUBING'S SILICONE PUMP SEGMENT NEAR THE UPPER FITMENT. THERE WAS NO PATIENT HARM. PHOTO OF THE TUBING WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088493 ↗
• MalfunctionApr 26, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  UNSPECIFIED TUBING EVENT. CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PRIMARY TUBING LEAKING AND CRACKED IN MULTIPLE PLACES. TUBING WAS PRIMED WITH DOPAMINE. REGISTERED NURSE NOTICED THAT AIR WAS PULLING INTO LINE MULTIPLE TIMES AND NEEDED TO BE RE-PRIMED LINE REQUIRED TO BE CHANGED."

  Patient problems: No Information

  MAUDE report 8557403 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "TPN WAS PRIMED AND READY TO HANG, THIS NURSE BEGAN TO PLACE IT INTO ALARIS PUMP WHEN TUBING DISCONNECTED AT SITE OF "PUMP SECTION" WHERE IT CONNECTS TO BLUE PLASTIC PIECE. TO BE SPECIFIC, THE TUBING HAD NOT EVEN BEEN PUSHED INTO PLACE WITHIN THE PUMP WHEN IT DISCONNECTED ON ITS OWN. THIS NURSE IMMEDIATELY ROLLER CLAMPED ABOVE AND BELOW BREAKAGE AND HELD ON TO BOTH PIECES TO INSURE STERILITY WAS MAINTAINED. RESOURCE NURSE WAS CALLED TO ASSIST, SHE BROUGHT NEW STERILE TUBING AND RE-SPIKED BAG WHILE THIS NURSE CONTINUED TO ENSURE ENDS OF OLD TUBING DIDN'T COME IN CONTACT WITH ANY SURFACES DURING THE TRANSFER. NO HARM WAS CAUSED TO PATIENT." AN INCOMPLETE DATE OF EVENT OF (B)(6)-2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8500210 ↗
• MalfunctionFeb 6, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE CUSTOMER REPORTED A SET THAT CONTAINED CHEMO CRACKED AND LEAKED AT AN UNSPECIFIED LOCATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8312845 ↗
• MalfunctionJan 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT CHEMO SPILLED FROM AN AREA OF THE TUBING THAT'S THE UNDER THE Y-SITE. THE CUSTOMER REPORTED THE SITE IS MARKED. THE MEDICATION DID NOT TOUCH THE PATIENT, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248762 ↗
• MalfunctionDec 20, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE CUSTOMER REPORTED THAT IN THE CLINICAL RESEARCH CENTER, 25 MINUTES INTO AN INFUSION, A PATIENT HEARD A CRACK WHEN MANEUVERING OUT OF BED. UPON ASSESSMENT, IT WAS NOTED THAT AN ENGAGEMENT OF A Y-SITE WAS BROKEN. CHEMOTHERAPY WAS IMMEDIATELY STOPPED ON THE PUMP MODULE, SPILL PRECAUTIONS WERE CARRIED OUT, THE PATIENT WAS INSTRUCTED TO WASH THEIR HANDS WITH SOAP AND WATER, THE PATIENT WAS MOVED TO ANOTHER ROOM, AND THE ROOM THE SPILL OCCURRED IN THE WAS CLEANED. THE CUSTOMER FURTHER CLARIFIES THAT NO CLOTHING WAS SOILED DURING THIS EVENT. NEW ORDERS WERE PLACED TO THE PATIENT TO RECEIVE THE REMAINDER OF THEIR DOSE. THE CUSTOMER REPORTED THE SEVERITY OF THIS EVENT AS "MILD". THERE'S NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187204 ↗