Alaris 10373772Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403234194), received between Feb 18, 2019 and Sep 21, 2022 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Crack” (10 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 21, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED THAT THE BD SMALLBORE IV EXTENSION SET WAS CRACKED, AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD EXTENSION SET SMALLBORE TUBING CRACKED AND LEAKED CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460365 ↗
• MalfunctionApr 10, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING SET "HUB" CRACKED AND LEAKED D10W AFTER FOUR HOURS AFTER THE INTRAVENOUS WAS PLACED. THE NURSE DOES NOT KNOW WHETHER THE TUBING SET WAS ALREADY CRACKED OR WHETHER THE CRACK OCCURRED WHEN IT WAS POSITIONED. THE EVENT OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9948123 ↗
• MalfunctionApr 8, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ARTERIAL LINE PRESSURE ALARM READ -2 AND THE NURSE NOTED A LARGE AMOUNT OF BLOOD ON THE BED. THE ARTERIAL LINE WAS THEN CLAMPED, PATIENT STATUS WAS CHECKED AND THE LINE WAS INSPECTED. IT WAS NOTED THAT THE EXTENSION SET HAD A CRACK AT ITS DISTAL END. THE EXTENSION SET WAS REPLACED AND PATIENT WAS CONTINUALLY MONITORED AND WAS STABLE. THE EVENT OCCURRED IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU)/CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934934 ↗
• InjuryFeb 19, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK ON THE DISTAL END OF THE EXTENSION TUBING SET. THE ARTERIAL LINE PRESSURE ALARM READ -2 WHEN CONNECTED TO A NEONATE AND THE NURSE NOTED A LARGE AMOUNT OF BLOOD ON THE PATIENT'S BED. THE LINE WAS CLAMPED AND THE EXTENSION SET WAS REPLACED. THE PATIENT REQUIRED CLOSE MONITORING AFTER STATUS CHECKED AND WAS FOUND TO BE STABLE. ADDITIONAL MONITORING PREVENTED FURTHER ADVERSE EFFECTS.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 9730982 ↗
• MalfunctionFeb 19, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB OF THE EXTENSION WAS FOUND TO BE CRACKED AND LEAKING FLUID. THE IV HAD JUST BEEN PLACED AND WAS APPROXIMATELY 4 HOURS OLD.

  Patient problems: No Information

  MAUDE report 9729811 ↗
• InjuryOct 11, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN INFUSION TPN/INTRALIPIDS VIA PCVC (PERCUTANEOUS CENTRAL VENOUS CATHETER) WITH THE T-CONNECTOR AND IV TUBING; THE RN OBSERVED LEAKING DUE TO A CRACK. THE RN STATED THE LEAK OCCURRED¿ FROM THE T-CONNECTOR AT THE JUNCTION BETWEEN WHERE IT SCREWS ON AND THE THIN PART OF THE TUBING STARTS¿. THE LINE WAS IN USE FOR 6/20/19-8/29/19. WHEN THE RN ATTEMPTED TO BE REMOVED BECAUSE OF THE RISK OF INFECTION FROM THE CRACK IN THE EXTENSION SET, THE PCVC CATHETER BROKE AND THE PATIENT HAD TO GO TO INTERVENTIONAL RADIOLOGY FOR THE REMOVAL OF THE REMAINDER OF THE LINE. THE INFANT ALSO REQUIRED A NEW LINE TO BE PLACED AT A LATER DATE. IT WAS LATER REPORTED UPON EXAMINATION OF THE T-CONNECTOR AFTER REMOVAL, IT WAS NOTED TO BE STIFF AND LESS PLIABLE THAN UNUSED PRODUCT. THE EVENT OCCURRED IN NICU.

  Patient problems: No Information

  MAUDE report 9178778 ↗
• MalfunctionFeb 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT PATIENTS COMING FROM THE ER TO THE PEDIATRIC INTERMEDIATE MEDICAL CARE UNIT HAD EXTENSION SETS THAT WOULD CRACK AND LEAK AT THE MALE COMPONENT UNDER THE SPIN COLLAR AT THE CONNECTION TO THE IV CATHETER. THIS HAS HAPPENED 5 TIMES IN THE LAST 2-3 WEEKS. AT TIMES, PERIPHERAL IVS HAD TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347802 ↗
• MalfunctionFeb 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT PATIENTS COMING FROM THE ER TO THE PEDIATRIC INTERMEDIATE MEDICAL CARE UNIT HAD EXTENSION SETS THAT WOULD CRACK AND LEAK AT THE MALE COMPONENT UNDER THE SPIN COLLAR AT THE CONNECTION TO THE IV CATHETER. THIS HAS HAPPENED 5 TIMES IN THE LAST 2-3 WEEKS. AT TIMES, PERIPHERAL IVS HAD TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347800 ↗
• MalfunctionFeb 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT PATIENTS COMING FROM THE ER TO THE PEDIATRIC INTERMEDIATE MEDICAL CARE UNIT HAD EXTENSION SETS THAT WOULD CRACK AND LEAK AT THE MALE COMPONENT UNDER THE SPIN COLLAR AT THE CONNECTION TO THE IV CATHETER. THIS HAS HAPPENED 5 TIMES IN THE LAST 2-3 WEEKS. AT TIMES, PERIPHERAL IVS HAD TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347799 ↗
• MalfunctionFeb 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT PATIENTS COMING FROM THE EMERGENCY ROOM TO THE PEDIATRIC INTERMEDIATE MEDICAL CARE UNIT HAD EXTENSION SETS THAT WOULD CRACK AND LEAK AT THE MALE COMPONENT UNDER THE SPIN COLLAR AT THE CONNECTION TO THE IV CATHETER. THIS HAS HAPPENED 5 TIMES IN THE LAST 2-3 WEEKS. AT TIMES, PERIPHERAL IVS HAD TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347798 ↗
• MalfunctionFeb 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT PATIENTS COMING FROM THE ER TO THE PEDIATRIC INTERMEDIATE MEDICAL CARE UNIT HAD EXTENSION SETS THAT WOULD CRACK AND LEAK AT THE MALE COMPONENT UNDER THE SPIN COLLAR AT THE CONNECTION TO THE IV CATHETER. THIS HAS HAPPENED 5 TIMES IN THE LAST 2-3 WEEKS. AT TIMES, PERIPHERAL IVS HAD TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347797 ↗