Alaris 2430-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 2 Y-Sites 294 cm (116 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alaris infusion pump set is a disposable IV administration set with a 0.2 micron filter, back check valve and two Y-sites. The 36 reports mostly describe the tubing leaking — holes, splits or punctures in the line or at connections, sometimes spilling chemotherapy or parenteral nutrition — with 3 injuries and no deaths. No recalls name this device, and there were no reports in the past 12 months or the 12 months before that.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07613203011396), received between May 11, 2018 and Feb 26, 2021 — classified as 3 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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
Device problems
- Fluid/Blood Leak23
- Material Puncture/Hole5
- Material Split, Cut or Torn5
- Leak/Splash4
- Excess Flow or Over-Infusion2
- Material Deformation2
- Crack1
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient22
- No Known Impact Or Consequence To Patient6
- No Information5
- No Patient Involvement2
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AS LVP 20D DEHP 2SS 0.2M CV LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1: MATERIAL #: 2430-0500 BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE IV SETS ARE LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11388639 ↗MalfunctionJul 7, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AS LVP 20D DEHP 2SS 0.2M CV TUBING HAD A HOLE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2430-0500 BATCH #: UNKNOWN. IT WAS REPORTED A HOLE IN SILICONE PART THAT IS INSERTED INTO THE PUMP AND LEAKAGE. "I HAVE A SET THAT HAS A HOLE IN THE SILICONE PART THAT IS INSERTED INSIDE THE PUMP. THE TUBING WAS HUNG AT THE END OF THE DAY SHIFT ON 6/14 AND DISCOVERED TO BE LEAKING (TPN DRIPPING ONTO FLOOR) DURING THE NIGHT THAT NIGHT".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10237953 ↗MalfunctionJun 24, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AS LVP 20D DEHP 2SS 0.2M CV LUER LOC DISCONNECTED FROM THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2430-0500 BATCH(LOT) NO: UNKNOWN. IT WAS REPORTED LUER LOC DISCONNECTED FROM TUBING SEGMENT WHICH RESULTED IN A CHEMO SPILL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10192201 ↗MalfunctionApr 13, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE TUBING HAS A HOLE AND IT LEAKED AT THE TOP PART OF THE PUMP SEGMENT WHILE PRIMING TOTAL PARENTERAL NUTRITION (TPN) ON A STERILE FIELD. THE SET WAS NOT CONNECTED TO THE PATIENT. THE EVENT OCCURRED IN NEONATAL INTENSIVE CARE UNIT. IT WAS CONFIRMED DURING FOLLOW UP THAT THERE WAS NO DELAY IN PATIENT CARE, AND THAT THIS EVENT DID NOT CONTRIBUTE TO, OR RESULT IN A SERIOUS ADVERSE IMPACT TO THE INFANT PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9953016 ↗MalfunctionApr 6, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AT (B)(6) THAT THE TUBING SET LEAKED. IT LEAKED FROM THE CONNECTION AT THE PROXIMAL END OF FILTER WHILE INFUSING. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 9931005 ↗MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE RN SPIKED THE BAG AND PREPARED TO INSERT THE TUBING INTO THE DEVICE, THE RN NOTICED THAT MEDICATION WAS LEAKING FROM THE MIDDLE SECTION "NOT NEAR A PORT OR CONNECTION." THE RN STATED; ¿AS IF THERE WAS A HOLE IN THE TUBING.¿ THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM. THE EVENT OCCURRED AT (B)(6) HEALTH CENTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9569320 ↗MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A ORENCIA INFUSION WAS INITIATED AT AN UNSPECIFIED RATE WHEN THE USER NOTED ON THE NEW TUBING BROKE AND LEAKED FROM THE MIDDLE SECTION OF THE TUBING AND NOT NEAR ANY PORTS OR CONNECTORS THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT HOWEVER MEDICATION WAS REMADE CAUSING A DELAY IN CARE. THE EVENT OCCURRED AT (B)(6) CENTER .
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9569317 ↗MalfunctionDec 30, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE TUBING LEAKED FROM A HOLE UNDERNEATH THE UPPER FITMENT. THIS EVENT OCCURRED IN THE NICU. 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 9531676 ↗MalfunctionNov 5, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE TUBING SET LEAKED FROM A HOLE BENEATH THE UPPER FITMENT IN PREPARATION OF AN IRON INFUSION. THE CUSTOMER VALIDATED THAT ALTHOUGH THE INFUSION WAS BEING PREPARED FOR ADMINISTRATION, THE TUBING SET WAS NOT ATTACHED TO THE ADULT PATIENT AT THE TIME OF THE EVENT, THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM CAUSED BY THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 9277990 ↗InjuryNov 1, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT A 5 MONTH OLD FEMALE PATIENT WAS RECEIVING TOTAL PARENTERAL NUTRITION (TPN) INFUSION WITH A SET RATE OF 26.8ML/HR THROUGH AN INFUSION PUMP THAT WAS STARTED ON (B)(6) 2019 AT 1758. THE TOTAL VOLUME OF THE TPN BAG WAS 570ML AND THE VOLUME TO BE INFUSED (VTBI) WAS 408ML. THE EVENT WAS DISCOVERED AT 2200 WHEN IT WAS NOTICED THAT THE VOLUME OF THE TPN WAS SIGNIFICANTLY LESS THAN EXPECTED. IT WAS NOTED THAT THE PATIENT RECEIVED "SEVERAL HUNDRED ML'S" OF TPN OVER THE SPAN OF 4 HOURS AND THE ESTIMATED VOLUME REMAINING WAS 100ML. THE PATIENT WAS TRANSFERRED TO PEDIATRIC INTENSIVE CARE UNIT AFTER THE EVENT. IT WAS REPORTED THAT DURING A NON-BD INVESTIGATION, THE DOOR HANDLE OF THE INFUSION PUMP WAS PARTIALLY CLOSED WHEN THE IV TUBING WAS IN USE AND THAT SOME TUBING IRREGULARITY WAS OBSERVED. A DIFFERENT SET OF IV TUBING WAS TESTED ON THE INVOLVED DEVICE AND FOUND THAT THE DOOR HANDLE WAS ABLE TO FULLY CLOSE. THE DEVICE EVENT LOG WAS REVIEWED BY THE FACILITY'S BIOMEDICAL PERSONNEL AND FOUND THAT THE INFUSION WAS PROGRAMMED CORRECTLY. ALTHOUGH REQUESTED, THERE WAS NO FURTHER INFORMATION REGARDING IMPACT TO THE PATIENT.
Patient problems: No Information
MAUDE report 9268871 ↗MalfunctionAug 20, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE TUBING SET HAD A HOLE AND LEAKED FROM THE SILICONE SEGMENT DURING A CARBOPLATIN INFUSION. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8909492 ↗MalfunctionAug 13, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE TUBING SET HAD A HOLE AND LEAKED FROM THE SILICONE SEGMENT IN PREPARATION FOR A RHMA GOLIMUMAB INFUSION THAT OCCURRED PRIOR TO BEING CONNECTED TO THE PATIENT THE MEDICATION WAS REMADE AND ADMINISTERED WITHOUT COMPLICATIONS. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Information
MAUDE report 8891286 ↗InjuryJun 12, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT A POSSIBLE OVER INFUSION OCCURRED DURING AN INFUSION, RESULTING IN A TRANSIENT ELEVATION OF THE INFANT'S BLOOD GLUCOSE. THE REPORT ALSO STATED THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION OR DETAILS OF THE EVENT PROVIDED.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8691798 ↗MalfunctionDec 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT IN THE NICU A TUBING LEAKED AFTER 12 HOURS OF INFUSING TPN. INTRAVENOUS FLUIDS WERE GIVEN AFTER THE LEAK. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8171896 ↗MalfunctionDec 12, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE TUBING HAD A CUT IN IT AND LEAKED AN UNSPECIFIED CHEMOTHERAPY AGENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8155161 ↗MalfunctionDec 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER LEAKED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8155157 ↗MalfunctionDec 11, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE TUBING HAD A CUT IN IT AND LEAKED AN UNSPECIFIED CHEMOTHERAPY AGENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8153889 ↗MalfunctionDec 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PATIENTS RECEIVING TPN/IL AND CARRIER FLUIDS VIA 3.5 DL UVC CENTRAL LINE IN THE NICU. PATIENT ALSO RECEIVING MULTIPLE BLOOD PRODUCTS WHICH REQUIRED THE CARRIER FLUIDS TO BE OFF LOADED TO THE SMARTSITE PORT CLOSEST TO THE PATIENT ON THE MAINTENANCE FLUID LINE (TPN). CARRIER FLUIDS WERE REPLACED TO UVC UNUSED PORT AFTER BLOOD PRODUCT INFUSION. IT WAS NOTED THAT SMARTSITE VALVE ON THE TPN LINE REMAINED ENGAGED AND WAS LEAKING TPN THRU SITE WHEN CARRIER FLUIDS WERE REMOVED. LINE CAPPED WITH DUAL CAP TO PREVENT FURTHER LEAKING AT SITE." NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8153798 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE TUBING HAD A CUT IN IT AND LEAKED AN UNSPECIFIED CHEMOTHERAPY AGENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8144563 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE TUBING HAD A CUT IN IT AND LEAKED AN UNSPECIFIED CHEMOTHERAPY AGENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8144287 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE TUBING HAD A CUT IN IT AND LEAKED AN UNSPECIFIED CHEMOTHERAPY AGENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8144054 ↗MalfunctionDec 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE SET LEAKED BLOOD AT THE CONNECTOR DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8135762 ↗InjuryNov 19, 2018Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT DURING INFUSIONS OF TPN D 8.5 AT A RATE OF 2.4ML/HOUR, IL AT 0.1ML/HOUR AND A CARRIER FLUID OF NS 0.45% AT 0.2ML/HOUR, THE SMARTSITE¿ ACCESS VALVE CLOSEST TO THE PATIENT REMAINED ENGAGED AFTER REMOVAL OF AN IV PIGGY BACK. THIS CAUSED THE TPN TO FLOW FREELY FROM THE TUBING SET. THE NURSE CAPPED THE PORT WITH A DUAL CAP TO PREVENT FLUID FROM LEAKING FROM THE SITE. THE PATIENT REQUIRED A FULL TUBING CHANGE THE NEXT MORNING WITH A NEW LINE PLACED WITHIN 10 HOURS OF THE EVENT OCCURRING. ALTHOUGH THERE WAS NO REPORTED HARM TO THE PATIENT, A SEPSIS WORKUP WAS IN PROGRESS ON 10/23/18 WITH BLOOD CULTURES PENDING. IT WAS LATER REPORTED THAT THE PATIENT DID NOT DEVELOP SEPSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8087706 ↗MalfunctionNov 12, 2018Material Deformation; Material Deformation
THE CUSTOMER REPORTED THAT THE TUBING SET DEVELOPED A BALLOON IN THE SILICONE SEGMENT DURING A CHEMOTHERAPY INFUSION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8060716 ↗MalfunctionNov 12, 2018Material Deformation; Material Deformation
THE CUSTOMER REPORTED THAT THE TUBING SET DEVELOPED A BALLOON IN THE SILICONE SEGMENT DURING A CHEMOTHERAPY INFUSION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8060545 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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