Alaris 2278-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885403223266), received between Feb 19, 2019 and Apr 13, 2026 — classified as 27 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 19, 2026Open, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT IS REPORTED, LEAKAGE. DESCRIPTION: IT WAS REPORTED BY CUSTOMER THAT PRODUCT IS DIFFICULT TO USE AND PRIMING THE BLOOD WITH THIS TUBING CREATES A MESS AND IS UNSANITARY. WRITE GOT BLOOD ON SKIN AND SCRUBS WHILE PRIMING LINE. TUBING ALSO REPEATEDLY CAUSES THE MACHINE TO BEEP IN ERROR WHEN THERE IS NO OBSERVABLE ISSUE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24863076 ↗
• MalfunctionMar 12, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583636 ↗
• MalfunctionNov 11, 2025Break; Material Separation; Air/Gas in Device; Break; Material Separation; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE PRIMARY TUBING HAD SNAPPED OFF AT ONE OF THE CONNECTION SITES. PUMP ALARMED AIR IN LINE. DRUG DID NOT START. TUBING REMOVED AND CONFIRMED WITH PHARMACY THAT DRUG WAS STILL INTACT AND ABLE TO BE ADMINISTERED. NEW PRIMARY TUBING OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529098 ↗
• MalfunctionNov 11, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT RN SPIKED PLATELETS AND THEY WOULD NOT PRIME PAST THE CHAMBER. ANOTHER RN ATTEMPTED WITH NO LUCK AS WELL. WASTED 5-10MLS OF PLATELETS AND THEY HAD THE SAME ISSUE AGAIN WITH THE SAME REF #. BLOOD TUBING WOULD NOT PRIME PAST THE CHAMBER, HAD TO WASTE APPROX. 10MLS OF PLATELETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529097 ↗
• MalfunctionNov 11, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT RN SPIKED PLATELETS AND THEY WOULD NOT PRIME PAST THE CHAMBER. ANOTHER RN ATTEMPTED WITH NO LUCK AS WELL. WASTED 5-10MLS OF PLATELETS AND THEY HAD THE SAME ISSUE AGAIN WITH THE SAME REF #. BLOOD TUBING WOULD NOT PRIME PAST THE CHAMBER, HAD TO WASTE APPROX. 10MLS OF PLATELETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529095 ↗
• MalfunctionJun 25, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT DID NOT PRIME PAST THE FILTER AND UNABLE TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331752 ↗
• MalfunctionJun 3, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT ALARIS PUMP INFUSION BLOOD SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT UNABLE TO PRIME BLOOD, STOPPED PRIMING AFTER THE FILTER PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137936 ↗
• MalfunctionMay 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005223 ↗
• MalfunctionMay 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY CUSTOMER THAT ALARIS PUMP INFUSION BLOOD SET WITH 200 MICRON FILTER STARTED LEAKING DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964749 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT BLOOD DRIPPING FROM THE PUMP A FEW SECONDS AFTER SETTING UP THE PUMP FOR BLOOD TRANSFUSION (PRBC). IT WAS NOTED THAT THE PUMP DID NOT INDICATE ANY ERRORS, AND THE TUBING WAS OKAY DURING PRIMING. IT WAS OBSERVED THAT BLOOD ONLY STARTED DRIPPING AFTER SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068798 ↗
• MalfunctionDec 5, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIAL # 2278-0500 BATCH # 24075304. IT WAS REPORTED BY CUSTOMER THAT BLOOD TUBING USED FOR BLOOD ADMINISTRATION SPRUNG A LEAK IN THE PORTION OF THE TUBING THAT IS SOFTER THAT SITS INSIDE OF THE IV PUMP CHANNEL. WHILE GETTING THE TRANSFUSION SET UP, REPORTER WENT TO CLOSE THE CHANNEL AND NOTICED SOME BLOOD DRIPPING DOWN THE TUBING. REPORTER OPENED CHANNEL BACK UP AND TOOK TUBING OUT OF THE CHANNEL AND BLOOD SQUIRTED OUT OF A SMALL HOLE IN THE TUBING. RCC RECEIVED A COMPLAINT VIA EMAIL. BLOOD TUBING USED FOR BLOOD ADMINISTRATION SPRUNG A LEAK IN THE PORTION OF THE TUBING THAT IS SOFTER THAT SITS INSIDE OF THE IV PUMP CHANNEL. WHILE GETTING THE TRANSFUSION SET UP, REPORTER WENT TO CLOSE THE CHANNEL AND NOTICED SOME BLOOD DRIPPING DOWN THE TUBING. REPORTER OPENED CHANNEL BACK UP AND TOOK TUBING OUT OF THE CHANNEL AND BLOOD SQUIRTED OUT OF A SMALL HOLE IN THE TUBING. LOT -24075304.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857780 ↗
• MalfunctionOct 31, 2024Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577279 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD BD ALARIS PUMP MODULE BLOOD INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT IV PUMP CHANNEL NOTED BLOOD THROUGHOUT. ¿ PARENT NOTICED BLOOD DRIPPING ON FLOOR, NOTIFIED RN. ¿ RN INVESTIGATED AND INSIDE IV PUMP CHANNEL NOTED BLOOD THROUGHOUT. ¿ SOURCE OF DAMAGE IN TUBING UNABLE TO BE IDENTIFIED. ¿ RN NOTIFIED BLOOD BANK WHO ADVISED TO CLAMP THE PORT SPIKED WITH TUBING. ¿ ADVISED THAT BAG OF BLOOD COULD STILL BE INFUSED WITH NEW TUBING IN OTHER AVAILABLE PORT. ¿ NEW TUBING HUNG. ¿ TRANSFUSION PROCEEDED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20538485 ↗
• MalfunctionOct 23, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD GEMINI BLOOD SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT ¿2 FEET OF AIR¿ IN IV SET 2278-0500 WHEN INFUSING PLATELETS.

  Patient problems: Insufficient Information

  MAUDE report 20514439 ↗
• MalfunctionAug 8, 2024Backflow; Backflow

  MATERIAL: UNKNOWN BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT RN WAS ABLE TO REMOVE THE SPIKE AND SPIKED THE NORMAL SALINE FLUSH. THE BLOOD BACKFLOWED FROM THE TUBING UP INTO THE NORMAL SALINE BAG CAUSING THE ENTIRE FLUSH TO GO PINK IN COLOUR AND DILUTED WITH BLOOD. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RN WAS ABLE TO REMOVE THE SPIKE AND SPIKED THE NORMAL SALINE FLUSH. THE BLOOD BACKFLOWED FROM THE TUBING UP INTO THE NORMAL SALINE BAG CAUSING THE ENTIRE FLUSH TO GO PINK IN COLOUR AND DILUTED WITH BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940461 ↗
• MalfunctionJul 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET WAS UNDER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE BLOOD TUBING SPIKE STUCK IN BLOOD BAG AT TIME OF FLUSH, RESULTING IN PATIENT NOT RECEIVING FINAL 30 ML FLUSH AND LOSING 30 ML PRBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806991 ↗
• MalfunctionJul 11, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED HERE IS THE SECOND REPORT OF THE PRBC TUBING BREAKING. I WROTE IT ON BEHALF OF THE STAFF, ALL DETAILS AND IMPACT TO THE PATIENT ARE IDENTICAL TO THE OTHER REPORT AND I DON'T HAVE THE TUBING SAVED FOR RETURNING TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719158 ↗
• MalfunctionJun 27, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET WAS DIFFICULT TO DISCONNECT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING : RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SAFETY REPORT (B)(4) BRIEF FACTUAL DESCRIPTION TUBING FROM PRBC BAG STUCK IN BAG. TOOK NUMEROUS PEOPLE TO PULL TUBING OUT OF BAG. ONCE IT WAS PULLED OUT, BLOOD BAG PORT BROKE OFF. UNABLE TO HANG FLUSH ON THE BLOOD TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630636 ↗
• MalfunctionMar 7, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD AIR LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAVE CREATED A PR 9705212 FOR THE PUMP COMPLAINT. CAN YOU ASSESS THE SOURCE MAIL AND CUSTOMER RESPONSE MAIL AND CONFIRM IF DISPOSABLE COMPLAINT IS NEEDED FOR THE SAME? IT WAS REPORTED THAT THERE WAS AIR IN THE LV SET LINE. THE CUSTOMER REPLACED THE IV TUBING, AND AIR WAS STILL NOTED. THERE WAS PATIENT INVOLVEMENT AND NO HARM. BD RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE AIR BUBBLES WERE IN THE TUBING WERE OBSERVED BELOW THE AIR-IN-LINE SENSOR ("ABOUT 6 INCHES BUBBLE OF AIR") AND THE DEVICE DID NOT ALARM AIR-IN-LINE. THE TUBING INVOLVED WAS BD ALARIS PUMP INFUSION BLOOD SET REF#2278-0500.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859363 ↗
• MalfunctionJan 18, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: HOPE YOU BOTH ARE DOING WELL AND ENJOYING SOME QUIET TIME DURING THE HOLIDAYS. I WANTED TO REACH OUT REGARDING OUR TRANSITION TO THE BD INFUSION SET WITH IN-LINE BLOOD FILTER (2278-0500) AND SOME CHALLENGES OUR STAFF ARE EXPERIENCING. WE HAVE RECEIVED MULTIPLE SAFETY REPORTS THAT WHEN BLOOD OR OTHER BLOOD PRODUCTS ARE RUNNING THROUGH THE INFUSION SET THERE ARE PARTS THROUGHOUT THE INFUSION SET WHICH HAS AIR IN THE LINE (SOME WITH LARGE AREAS). SINCE THERE IS NO EXTRA PORT TO WITHDRAW THE AIR FROM, STAFF ARE THEN NEEDING TO STOP THE LINE, PRIME A NEW TUBING SET AND START AGAIN, RESULTING IN LOST TIME AND PRODUCT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536843 ↗
• MalfunctionSep 5, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD AIR BUBBLES AND AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: "ONE OF THE NURSES BROUGHT ME THE PACKAGING FOR A BLOOD SET USED IN THE ED. SEE PICS BELOW. THIS TUBING WAS SET UP ON AN ALARIS PUMP, THE NURSES PROGRAMMED THE PUMP, HIT START AND THEN SAW THE AIR IN THE TUBING . THIS AIR WAS NOT IN PLACE WHEN THEY INITIALLY PRIMED THE PUMP. THEY BLED OUT THIS AIR AND SET UP THE PUMP AGAIN. THE PUMP WAS THEN STARTED AND THE INFUSION BEGAN, THE PUMP ALARMED. THE NURSES RETURNED TO THE ROOM AND FOUND AIR IN THE TUBING AGAIN. ONE OF THE NURSES WORKING IN THE SAME AREA HAD THIS SAME THING HAPPEN EARLIER THIS WEEK BUT THOUGHT IT WAS A SINGULAR EVENT. THE NURSE THAT SENT ME THESE PICS HAD IT HAPPEN LAST WEEK. THIS IS A PATIENT SAFETY ISSUE AND NEEDS URGENT ATTENTION".

  Patient problems: Insufficient Information

  MAUDE report 17687230 ↗
• MalfunctionMay 23, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE NON-VENTED BLOOD SET HAD AIR IN THE LINE AFTER PRIMING THE PLATELETS WITH BLOOD PRODUCT AND STARTING THE TRANSFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AIR IN LINE... PLATELETS ORDERED FOR PATIENT. PLATELETS PRIMED WITH BLOOD PRODUCT TUBING PER PROTOCOL. RN STAYED IN THE ROOM FOR 15 MINUTES DOING LINE DRESSING CHANGE, AND 10 MINUTES INTO TRANSFUSION AIR-IN-LINE STARTED ALARMING. ABOUT 12 INCHES OF AIR FROM END OF DRIP CHAMBER TO BELOW MODULE END. INFUSION STOPPED AND NEW BLOOD PRODUCT TUBING PRIMED. INFUSION CONTINUED WITHOUT ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987139 ↗
• MalfunctionApr 8, 2019Emergency Power Failure; Fluid/Blood Leak; Emergency Power Failure; Fluid/Blood Leak

  IT WAS REPORTED THAT TUBING WAS LEAKING BELOW THE UPPER BLUE FITMENT / SILICONE SEGMENT.

  Patient problems: No Information

  MAUDE report 8491757 ↗
• MalfunctionMar 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT DURING AN INFUSION THERE WAS LEAKING FROM BELOW THE UPPER FITMENT/SILICONE TUBING CONNECTION. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 8449455 ↗
• MalfunctionMar 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT DURING AN INFUSION THERE WAS LEAKING FROM BELOW THE UPPER FITMENT/SILICONE TUBING CONNECTION. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 8449454 ↗