Alaris 10015612Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403234040), received between Sep 11, 2018 and Oct 17, 2018 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 16, 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.

• InjuryOct 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FOUR SETS LEAKED AT THE CONNECTION TO A DIFFERENT MANUFACTURER'S NEEDLELESS CONNECTOR DURING A PATIENT'S INFUSION. THE FOUR INFUSIONS (EPINEPHRINE, MILRINONE, ARTERIAL LINE, CVP LINE) WERE STARTED DURING THE EVENING OF (B)(6) 2018 ON THE NIGHT SHIFT TO RUN INTO A STERILE CONTAINER UNTIL THE TIME FOR THE TUBING CHANGE. EARLY IN THE MORNING ON (B)(6) 2018, THE NEW TUBING ¿TREE¿ (IV POLE WITH PC UNIT AND ATTACHED PUMP MODULES) WAS CONNECTED TO THE PATIENT AND THE OLD ¿TREE¿ WAS REMOVED. THERE WAS NO REPORT OF A LEAK AT THIS TIME. THE PATIENT¿S BLOOD PRESSURE STARTED TO DECLINE THE MORNING OF (B)(6) 2018 DESPITE DOSE ADJUSTMENTS. THE EPINEPHRINE TUBING WAS WET BETWEEN THE MICROCLAVE AND THE TUBING, AND WETNESS WAS OBSERVED FURTHER DOWN THE TUBING. UPON INSPECTION, THE USER DISCOVERED THAT THE MILRINONE, ARTERIAL LINE AND CVP LINES WERE ALSO DAMP AT THE CONNECTIONS TO THE NEEDLELESS CONNECTORS, INDICATING LEAKS. AFTER THE LEAKS WERE DISCOVERED, THE TUBING WAS CHANGED AND THE PATIENT¿S BLOOD PRESSURE SUBSEQUENTLY STABILIZED WITH NO OTHER EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7975720 ↗
• InjuryOct 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FOUR SETS LEAKED AT THE CONNECTION TO A DIFFERENT MANUFACTURER'S NEEDLELESS CONNECTOR DURING A PATIENT'S INFUSION. THE FOUR INFUSIONS (EPINEPHRINE, MILRINONE, ARTERIAL LINE, CVP LINE) WERE STARTED DURING THE EVENING OF (B)(6) 2018 ON THE NIGHT SHIFT TO RUN INTO A STERILE CONTAINER UNTIL THE TIME FOR THE TUBING CHANGE. EARLY IN THE MORNING ON (B)(6) 2018, THE NEW TUBING ¿TREE¿ (IV POLE WITH PC UNIT AND ATTACHED PUMP MODULES) WAS CONNECTED TO THE PATIENT AND THE OLD ¿TREE¿ WAS REMOVED. THERE WAS NO REPORT OF A LEAK AT THIS TIME. THE PATIENT¿S BLOOD PRESSURE STARTED TO DECLINE THE MORNING OF (B)(6) 2018 DESPITE DOSE ADJUSTMENTS. THE EPINEPHRINE TUBING WAS WET BETWEEN THE MICROCLAVE AND THE TUBING, AND WETNESS WAS OBSERVED FURTHER DOWN THE TUBING. UPON INSPECTION, THE USER DISCOVERED THAT THE MILRINONE, ARTERIAL LINE AND CVP LINES WERE ALSO DAMP AT THE CONNECTIONS TO THE NEEDLELESS CONNECTORS, INDICATING LEAKS. AFTER THE LEAKS WERE DISCOVERED, THE TUBING WAS CHANGED AND THE PATIENT¿S BLOOD PRESSURE SUBSEQUENTLY STABILIZED WITH NO OTHER EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7975718 ↗
• InjuryOct 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FOUR SETS LEAKED AT THE CONNECTION TO A DIFFERENT MANUFACTURER'S NEEDLELESS CONNECTOR DURING A PATIENT'S INFUSION. THE FOUR INFUSIONS (EPINEPHRINE, MILRINONE, ARTERIAL LINE, CVP LINE) WERE STARTED DURING THE EVENING OF (B)(6) 2018 ON THE NIGHT SHIFT TO RUN INTO A STERILE CONTAINER UNTIL THE TIME FOR THE TUBING CHANGE. EARLY IN THE MORNING ON (B)(6) 2018, THE NEW TUBING ¿TREE¿ (IV POLE WITH PC UNIT AND ATTACHED PUMP MODULES) WAS CONNECTED TO THE PATIENT AND THE OLD ¿TREE¿ WAS REMOVED. THERE WAS NO REPORT OF A LEAK AT THIS TIME. THE PATIENT¿S BLOOD PRESSURE STARTED TO DECLINE THE MORNING OF (B)(6) 2018 DESPITE DOSE ADJUSTMENTS. THE EPINEPHRINE TUBING WAS WET BETWEEN THE MICROCLAVE AND THE TUBING, AND WETNESS WAS OBSERVED FURTHER DOWN THE TUBING. UPON INSPECTION, THE USER DISCOVERED THAT THE MILRINONE, ARTERIAL LINE AND CVP LINES WERE ALSO DAMP AT THE CONNECTIONS TO THE NEEDLELESS CONNECTORS, INDICATING LEAKS. AFTER THE LEAKS WERE DISCOVERED, THE TUBING WAS CHANGED AND THE PATIENT¿S BLOOD PRESSURE SUBSEQUENTLY STABILIZED WITH NO OTHER EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7975715 ↗
• InjuryOct 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FOUR SETS LEAKED AT THE CONNECTION TO A DIFFERENT MANUFACTURER'S NEEDLELESS CONNECTOR DURING A PATIENT'S INFUSION. THE FOUR INFUSIONS (EPINEPHRINE, MILRINONE, ARTERIAL LINE, CVP LINE) WERE STARTED DURING THE EVENING OF (B)(6) 2018 ON THE NIGHT SHIFT TO RUN INTO A STERILE CONTAINER UNTIL THE TIME FOR THE TUBING CHANGE. EARLY IN THE MORNING ON (B)(6) 2018, THE NEW TUBING ¿TREE¿ (IV POLE WITH PC UNIT AND ATTACHED PUMP MODULES) WAS CONNECTED TO THE PATIENT AND THE OLD ¿TREE¿ WAS REMOVED. THERE WAS NO REPORT OF A LEAK AT THIS TIME. THE PATIENT¿S BLOOD PRESSURE STARTED TO DECLINE THE MORNING OF (B)(6) 2018 DESPITE DOSE ADJUSTMENTS. THE EPINEPHRINE TUBING WAS WET BETWEEN THE MICROCLAVE AND THE TUBING, AND WETNESS WAS OBSERVED FURTHER DOWN THE TUBING. UPON INSPECTION, THE USER DISCOVERED THAT THE MILRINONE, ARTERIAL LINE AND CVP LINES WERE ALSO DAMP AT THE CONNECTIONS TO THE NEEDLELESS CONNECTORS, INDICATING LEAKS. AFTER THE LEAKS WERE DISCOVERED, THE TUBING WAS CHANGED AND THE PATIENT¿S BLOOD PRESSURE SUBSEQUENTLY STABILIZED WITH NO OTHER EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7975657 ↗
• InjurySep 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING AN EPINEPHRINE INFUSION, A LEAK OCCURRED BETWEEN THE NEEDLELESS VALVE AND THE PSD TUBING WITH THE LAST 10-15 ML OF THE INFUSION. THE EVENT WAS DISCOVERED WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED UNEXPECTEDLY. THE RATE WAS UNDER 5 ML/HR. THE MD WAS NOTIFIED AND A NEW MEDICATION WAS ORDERED IN A NEW SYRINGE. THE PATIENT¿S BLOOD PRESSURE STABILIZED WITH NO LASTING EFFECTS OF THE EVENT REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7873187 ↗
• MalfunctionSep 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING A HEPARIN INFUSION, THE LEAK WAS DISCOVERED WITH THE LAST 10-15 ML OF THE INFUSION BETWEEN THE NEEDLELESS VALVE AND THE PSD TUBING. THE RATE WAS UNDER 5 ML/HR. THE CLINICIAN OBTAINED A NEW SYRINGE AND TUBING TO CONTINUE THE PATIENT¿S INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866820 ↗
• MalfunctionSep 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING A CALCIUM CHLORIDE INFUSION, A LEAK WAS DISCOVERED WITH THE LAST 10-15 ML OF THE INFUSION BETWEEN THE NEEDLELESS VALVE AND THE PSD TUBING. THE RATE WAS UNDER 5 ML/HR. THE CLINICIAN OBTAINED A NEW SYRINGE AND TUBING TO CONTINUE THE PATIENT¿S INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866785 ↗