Alaris MS3500Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403222603), received between Jul 27, 2018 and Sep 2, 2022 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD SECONDARY ADMINISTRATION SET BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDICINE STARTING POURING OUT AS THE SECONDARY TUBE WAS BROKEN AFTER SPIKING THE MINI BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352762 ↗
• MalfunctionAug 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 36 IN 20 DROP SECONDARY SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SECONDARY TUBING BECAME DISCONNECTED AT THE FLUID CHAMBER CAUSING MEDICATION TO COME GUSHING OUT OF CHAMBER ON THE CHAMBER SIDE AND BACKFLOW OUT OF THE TUBING SIDE. DID NOT REACH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298919 ↗
• MalfunctionJul 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 36 IN 20 DROP SECONDARY SET EXPERIENCED COMPONENT SEPARATION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING TAKEN OUT OF PACKAGING AND TUBING WAS DISCONNECTED FROM THE SPIKE CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215105 ↗
• MalfunctionJun 3, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE NOTICED IN THE SECONDARY TUBING SET CAUSING AN UNSPECIFIED FLUID TO LEAK ONTO THE NURSE WHILE PRIMING. THIS OCCURRED IN ONCOLOGY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10114225 ↗
• MalfunctionDec 27, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE COMPLETION OF CEFTOLOZANE/TAZOBACTAM1,000MG IN 100ML NS SECONDARY INFUSION, A LEAK WAS OBSERVED AT THE CONNECTION BETWEEN SECONDARY AND PRIMARY SETS. POTASSIUM CHLORIDE 20MEQ WAS INFUSING THROUGH THE PRIMARY SET. IT WAS NOTED THAT THE CONNECTION BETWEEN TWO SETS WAS TIGHT AND NO CRACK WAS SEEN. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9525771 ↗
• MalfunctionSep 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE NURSE HAD JUST REMOVED THE IV TUBING SET FROM THE PACKAGE. THE IV BAG WAS SPIKED WITH THE SET, AND WHEN THE NURSE SQUEEZED THE DRIP CHAMBER TO PRIME THE SET, THE TUBING SEPARATED FROM THE BOTTOM OF THE DRIP CHAMBER. THE EVENT OCCURRED DURING PRIMING; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9135595 ↗
• MalfunctionSep 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE RN SPIKED THE BAG OF IV POTASSIUM IV PIGGYBACK USING SECONDARY TUBING AND THE TUBING CAME APART BELOW THE DRIP CHAMBER. THE EVENT OCCURRED PRIOR TO CONNECTING THE IV TUBING TO THE PATIENT. THERE WAS NO PATIENT HARM. PHOTO OF THE IV TUBING WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084072 ↗
• MalfunctionAug 27, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT TUBING WAS HUNG ON NIGHT SHIFT FOR IV TYLENOL. THE MEDICATION DID NOT INFUSE, BUT IT WAS DISCOVERED THAT THE VENT ON THE TUBING HAD NOT BEEN OPENED. THE VENT WAS OPENED AND THE MEDICATION STILL DID NOT INFUSE. THERE WAS NO PATIENT HARM.

  Patient problems: No Information

  MAUDE report 8934022 ↗
• MalfunctionApr 18, 2019Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  IT WAS REPORTED THAT THE SECONDARY CHEMOTHERAPY INFUSION WOULD NOT FLOW THROUGH THE PRIMARY LINE UNLESS THE PRIMARY CLAMP WAS CLOSED THEN REOPENED TO ALLOW THE CHEMO TO INFUSE. THEY INDICATED THERE WAS A MINOR AFFECT ON THE PATIENT SINCE THERE WAS AN INACCURATE ADMINISTRATION OF CHEMOTHERAPY. THEY STATED THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529548 ↗
• InjuryApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN INFUSION OF VERSED TO A PATIENT IN THE NICU, IT WAS NOTED THAT LEAKING WAS OBSERVED AT THE POINT WHERE THE TUBING SET WAS CONNECTED TO A NEEDLELESS CONNECTOR. A MINOR AFFECT WAS REPORTED TO HAVE OCCURRED SINCE THE PATIENT WAS NOT RECEIVING A RELIABLE INFUSION OF THE SEDATION MEDICATION. THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY AND WAS HAVING BLOOD PRESSURE AND INTRACRANIAL PRESSURE FLUCTUATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Pain Relief; Therapeutic Response, Decreased

  MAUDE report 8527892 ↗
• InjuryJul 27, 2018Break; Break

  THE CUSTOMER REPORTED THAT WHEN THE RN WAS DISCONNECTING THE "MED-COMP" TUBING FROM A BMT (BONE MARROW TRANSPLANT) PATIENT IT WAS DIFFICULT TO SEPARATE. THE RN USED A HEMOSTAT TO SEPARATE THE TUBING AND THE TUBING BROKE WITH A SMALL PART REMAINING IN THE LUMEN OF THE SET. AS A RESULT , THE PATIENT HAD A NEW LINE SURGICALLY REPLACED AND EXTRA MEDICATION HAD TO BE GIVEN DUE TO THE DELAY OF A STEM CELL TRANSFUSION. THERE WAS NO LASTING HARM HOWEVER THE PATIENT DEVELOPED A CLABSI 8 DAYS LATER; THE CUSTOMER STATED THEY DON'T THINK THIS WAS NECESSARILY RELATED.

  Patient problems: Therapeutic Response, Decreased; Unspecified Infection

  MAUDE report 7728996 ↗