Alaris 11448964Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10885403234743), received between Sep 10, 2018 and Dec 9, 2024 — classified as 4 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Material Separation” (54 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL #: 11448964. BATCH#: 23019376. IT WAS REPORTED BY CUSTOMER THAT THE OPERATOR SET UP A SECONDARY INFUSION, CONNECTING TO A PRIMARY SET THAT ROUTED THROUGH AN INFUSION PUMP. THE PRIMARY SET WAS EQUIPPED WITH THE REQUIRED BACK-CHECK VALVE FOR A SECONDARY INFUSION. THE SECONDARY SET WAS SPIKED INTO A GLASS CONTAINER WITH THE DRIP CHAMBER VENT OPEN. THE PRIMARY LINE WAS SPIKED INTO AN IV BAG WITH THE VENT CLOSED. THE SECONDARY CONTAINER WAS POSITIONED WITH THE FLUID LEVEL 39 CM HIGHER THAN THE FLUID LEVEL IN THE PRIMARY CONTAINER. A 500 ML/HR INFUSION WAS STARTED ON THE INFUSION PUMP. OBSERVING THE DRIP CHAMBERS IT WAS EVIDENT THAT THE MAJORITY OF FLOW WAS COMING FROM THE PRIMARY CONTAINER. WHEN THE OPERATOR INSPECTED THE VENT ON THE SECONDARY DRIP CHAMBER AND GENTLY TAPPED IT WITH A HEMOSTAT, THE FLOW SWITCHED TO COMING PRIMARILY THROUGH THE SECONDARY CONTAINER INSTEAD OF THE PRIMARY CONTAINER. RCC RECEIVED A COMPLAINT VIA EMAIL. OPERATOR SET UP A SECONDARY INFUSION, CONNECTING TO A PRIMARY SET THAT ROUTED THROUGH AN INFUSION PUMP. THE PRIMARY SET WAS EQUIPPED WITH THE REQUIRED BACK-CHECK VALVE FOR A SECONDARY INFUSION. THE SECONDARY SET WAS SPIKED INTO A GLASS CONTAINER WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880418 ↗
• MalfunctionAug 20, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005896 ↗
• MalfunctionJun 5, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. (B)(6) RN SAID, SHE CONTINUES TO GET AIR BOLUSES WHEN PRIMING AND ADMINISTERING A SECONDARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467750 ↗
• MalfunctionFeb 6, 2024Disconnection; Separation Problem; Disconnection; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM REPORTED DETAILS: RECORD OPENED IN RELATION TO EXISTING COMPLAINTS RELATED TO LUER LOCK DISCONNECTIONS. SAMPLE WAS RECEIVED AS PART OF EXISTING INVESTIGATIONS AND IDENTIFIED THE LUER MAY NOT BE COMPATIBLE WITH OPTIMA INJECTOR LUER , IT WAS DETECTED THAT THE DIMENSIONS OF THE CONNECTOR OF THE IV-SET DO NOT COMPLY WITH ISO 80369-7:2021(E). PER INITIAL REPORT : LINE DISCONNECTED AT SECONDARY PIGGY BACK PORT. ETOPOSIDE RUNNING. BD PHASEAL OPTIMA INJECTOR PRODUCT #515052 LUERED OFF AT END OF SECONDARY LINE. RESULTED IN OPENING SYSTEM, LOSS OF DRUG DOSE ETOPOSIDE, AND EXPOSURE TO HAZARDOUS DRUG.

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

  MAUDE report 18652400 ↗
• MalfunctionJan 30, 2024Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 11448964, LOT#: 23073035. IT WAS REPORTED BY THE CUSTOMER REPORTED "SPIKED MINI BAG WITH MAGNESIUM IN IT AND SECONDARY SET BAG SPIKE BROKE IN BAG AND MAGNESIUM LEAKED OUT ON TO NURSE. THE PHYSICAL SET IN THE CANCER CARE SPACE WILL ALSO MAKE CLEAR THE ISSUE." VERBATIM: "SPIKED MINI BAG WITH MAGNESIUM IN IT AND SECONDARY SET BAG SPIKE BROKE IN BAG AND MAGNESIUM LEAKED OUT ON TO NURSE. THE PHYSICAL SET IN THE CANCER CARE SPACE WILL ALSO MAKE CLEAR THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608517 ↗
• MalfunctionOct 24, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET CLAMP WAS DEFECTED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: IT WAS REPORTED BY CUSTOMER THAT ALARIS SECONDARY TUBING IN WHICH THE CLAMP WAS PLACED INCORRECTLY (OPPOSITE DIRECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993445 ↗
• MalfunctionSep 25, 2023Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET FLUID BACK FLOWED INTO PRIMARY SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE HAD A RECENT ISSUE IN THE CHEMO SUITE WITH A CHEMO DRUG NOT INFUSING PROPERLY TO THE PERIPHERAL LINE. WE ARE NOT SURE IF WE ARE EXPERIENCING FAULTY TUBING OR FAULTY PHASEAL PRODUCTS. DESPITE BEING PROGRAMMED ON A PUMP CORRECTLY WHEN STARTED THE SECONDARY LINE WAS RUNNING AT A FAST RATE AND IT APPEARED TO BE INFUSING UP TO THE PRIMARY LINE (DESPITE CLAMPS BEING IN PLACE) NOT TO THE PATIENT. THERE IS NOW CHEMO IN THE PRIMARY AND SECONDARY LINE. WHEN WE HAVE COME ACROSS FAULTY TUBING ISSUES PREVIOUSLY, WE HAVE SENT THEM OFF TO BD FOR INVESTIGATION¿.NOT SURE THIS IS POSSIBLE IN THIS SITUATION GIVEN I HAVE ALMOST A FULL BAG OF CHEMO WITH PATIENT IDENTIFIERS ON IT. I DO HAVE PACKING TO SHIP CYTOTOXIC LINES BUT IF WE DISCONNECT THE IV MEDS WE WILL ENCOUNTER STAFF EXPOSURE. THOUGHTS ON HOW BEST TO REPORT/INVESTIGATE THIS ISSUE. WE DO NOT HAVE ANY OF THE ORIGINAL PACKAGING WITH THE PRODUCTS USED TODAY SO I CANNOT CONFIRM THE LOT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 17814709 ↗
• MalfunctionAug 23, 2023Backflow; Backflow

  NO ADDITIONAL INFORMATION. MATERIAL#:11448964, BATCH#: UNKNOWN. SECONDARY MEDICATION HUNG AND PROGRAMMED TO RUN WITH A VTBI OF 31ML (+25ML FLUSH) AT A RATE OF 124ML/H (OVER 15 MINUTES), BUT MEDICATION INFUSED MUCH MORE QUICKLY WITH THE VOLUME IN THE BAG DECREASING RAPIDLY OVER A COUPLE MINUTES. WHEN THE PUMP WAS PAUSED THE MEDICATION CONTINUED TO INFUSE UNTIL LINE CLAMPED (MMS PUMP PR8627530). THE CHARGE NURSE ALSO NOTES THAT THE PRIMARY BAG STARTED EMPTYING RAPIDLY AFTER THE SECONDARY BAG. APPEARS TO BE A PRIMARY SET BCV FAILURE. BIOMED FINDINGS SO FAR: OBTAINED THE ERROR AND EVENT LOGS TO BOTH THE LVP AND THE PCU (SEE ATTACHED). ERROR LOGS INDICATE A HISTORY OF PATIENT SIDE OCCLUSIONS DUE TO A VERY LOW VOLTAGE ON THE PATIENT-SIDE PRESSURE SENSOR. THERE IS NOTHING TO INDICATE THAT THIS WAS SIGNIFICANT TO THE PROBLEM AT HAND. USED THE LOGS TO REPLICATE THE INFUSION SETTINGS FOR BIOMED TESTING. NO ISSUES WITH HOW USER PROGRAMMED DEVICE. ONE WAY VALVE ON THE PRIMARY TUBING SEEMS TO BE BROKEN AS IT IS LETTING FLUIDS THROUGH BOTH DIRECTIONS (AFTER OCCLUDING THE PATIENT SIDE). WHEN THE PATIENT SIDE IS OCCLUDED, THE SECONDARY IS STILL DRIPPING, HOWEVER, THE FLUID GOES THROUGH THE PRIMARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607969 ↗
• MalfunctionAug 23, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607380 ↗
• MalfunctionJul 13, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET THE IV SE BROKE AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: SECONDARY SET BROKE AS I SPIKED LEUCOVORIN (TUBING DETACHED FROM DRIP CHAMBER). THIS RESULTED IN THE LEUCOVORIN SPILLING AND HAVING TO BE REMADE BY PHARMACY. IMPACT OF INCIDENT: DELAY WHILE NEW MED BAG OBTAINED FROM PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322292 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET SEPARATION AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BD SECONDARY KIT WAS OPEN AND USED TO SPIKE A BAG OF MEDICATION. THE TUBING BROKE JUST BELOW THE DRIP CHAMBER CAUSING THE MEDICATION TO SPILL OUT. A SECOND BD SECONDARY KIT FROM THE SAME LOT WAS THEN OPENED AND ALSO BROKE IN THE SAME LOCATION, JUST BELOW THE DRIP CHAMBER. MEDICATION WASTED; EXPOSURE OF STAFF TO POTENTIALLY HARMFUL MEDICATIONS BOTH TUBING SAVED FOR RETURN IF DEEMED NECESSARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17095597 ↗
• MalfunctionJun 7, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET COMPONENTS SEPARATED IMPROPERLY AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DATE: (B)(6) 2023. DETAILS OF COMPLAINT (REPORTED ISSUE): PRODUCT: BD SECONDARY SET 36 IN. VMID: (B)(4). LOT NUMBER: (10)22119366. PRODUCT EXPIRY DATE: 24-NOV-2025. NUMBER OF DEFECTIVE PRODUCT(S): 1 IS SAMPLE AVAILABLE: YES CONCERN DESCRIPTION: IV TUBING SEPARATED JUST BELOW DRIP CHAMBER AND MEDICATION SOME LEAKED OUT BEFORE RN PUT HER FINGER TO STOP THE FLOW OF FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081025 ↗
• MalfunctionJun 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 20 BD ALARIS¿ SECONDARY SETS FROM LOT 21113390, AND 1 SET FROM LOT 20093376 HAD ISSUES WITH THEIR TUBING BEING DISCOLORED TO BROWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING HAS TURNED A BROWN COLOUR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062131 ↗
• MalfunctionMay 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY PRODUCT- CONNECTION BETWEEN THE DRIP CHAMBER AND THE IV TUBING LEAKING IV FLUID. PRODUCT: BD SECONDARY SET REF# (B)(4). PRODUCT COMPLAINT FORM FILLED OUT. IV FLUID INCLUDED CHEMO-FLUIDS, WHICH WAS EXTREMELY DANGEROUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959358 ↗
• MalfunctionMay 11, 2023Backflow; Backflow

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET BACKFLOW OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POTENTIAL BACKCHECK VALVE (BCV) FAILURE MICAFUNGIN IV HUNG ON SECONDARY LINE AT APPROXIMATED 0835H AND PROGRAMMED TO RUN OVER 1 HR. AT APPROX. 0850H WRITER NOTICED THAT MICAFUNGIN BAG WAS COMPLETELY EMPTY BUT VTBI ON PUMP STILL SHOWING APPROX 85ML (TOTAL VOLUME 110ML). DRIP CHAMBER OF PRIMARY LINE COMPLETELY FULL, BUT HAD ONLY BEEN 1/2 FULL BEFORE INFUSION. INFUSION WAS STOPPED AND IV TUBING SWITCHED OUT FOR NEW PRIMARY + SECONDARY TUBING. MD NOTIFIED AND MICAFUNGIN DOSE REPEATED PER MD. PROBABLE FAILED BACK CHECK VALVE BD ALARIS PUMP INFUSION SET (REF # (B)(6), BD SECONDARY SET (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916246 ↗
• MalfunctionMay 5, 2023Backflow; Backflow

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET BACK FLOWED TO THE PRIMARY BAG CHAMBER INSTEAD OF ADMINISTERING TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SECONDARY MEDICATION BACK FLOWED UP TO THE PRIMARY BAGS CHAMBER INSTEAD OF ADMINISTERING TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882165 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET LINE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN INCIDENT IN THE CHEMO CLINIC WITH THE SECONDARY LINE BREAKING.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872772 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPIKE TUNNEL SNAPPED OFF THE IV BAG. THE EVENT OCCURRED ON (B)(6) 2023 DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687132 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:11448964; BATCH #:22113086. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING SNAPPED AND COMPLETELY BROKE FROM BOTTOM OF DRIP CHAMBER. CUSTOMER: MAT# AL11448964, LOT# (10) 22113086, DETAILS OF COMPLAINT (REPORTED ISSUE): CONCERN DESCRIPTION: SPIKED IV MED USING THE SECONDARY LINE TUBING AND THE TUBING SNAPPED AND COMPLETELY BROKE FROM BOTTOM OF DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637885 ↗
• MalfunctionMar 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET THE TUBING SEPARATED AT THE PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS ALSO A PUMP SEGMENT SEPARATION RECEIVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615077 ↗
• MalfunctionMar 24, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET CAME APART WHERE THE TUBING AND CHAMBER CONNECTED AND SPILLED OUT GEMCITABINE OVER THE TABLE AND PHARMACIST. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO TUBING SETS: REF# (B)(4), AND THE SECONDARY SETS WITH THE TEXIUM CLOSED SET, REF# (B)(4), HAVE BEEN LEAKING OR COMING APART AT WHERE THE CHAMBER AND THE TUBING ARE SUPPOSED TO BE SEALED TOGETHER. YESTERDAY, WE HAD A SET COME APART AND LEAK GEMCITABINE ALL ACROSS THE TABLE IN THE CLEANROOM. CUSTOMER IS LOOKING TO SEE IF OTHER FACILITIES ARE HAVING ISSUES OR WHAT THE CAUSE COULD BE... BOTH ISSUES OCCURRED SEPARATELY. THE SET WITH THE TEXIUM ATTACHED TO IT, REF# (B)(4), DID FALL APART AND THE CHEMO THAT WAS IN IT CAME IN CONTACT WITH ONE OF OUR PHARMACISTS FROM THE WAIST DOWN. FORTUNATELY, NO MEDICAL INTERVENTION WAS REQUIRED. WE DO HAVE A SET, REF# (B)(4), THAT FELL APART BEFORE WE EVEN ATTACHED IT TO THE BAG. WE ALSO HAVE TWO BAGS WITH THE FLUID CHAMBER CONNECTED TO THE BAG, BUT THE TUBING HAD COME APART."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615074 ↗
• MalfunctionMar 13, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED WHILE USING BD ALARIS¿ SECONDARY SET AIR WAS FOUND IN LINE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN ATTEMPTING TO PRIME SECONDARY SET, NOTABLE AIR IN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527308 ↗
• MalfunctionMar 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET BROKE BELOW DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: JAN 30: SECONDARY LINE BROKE WHEN CHECKED, BROKE BELOW DRIP CHAMBER. LOT (10)22103532 - LINE DOES NOT CONTAIN ANY DRUG OR SOLUTION (NON-CYTOTOXIC).

  Patient problems: Insufficient Information

  MAUDE report 16519277 ↗
• MalfunctionMar 8, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD SECONDARY ADMINISTRATION SET WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW IV SECONDARY SET HAD A CUT IN THE TUBING. AFTER ATTACHING A BRAND NEW SECONDARY IV SET TO A SALINE IV LINE THAT WAS CONNECTED TO PATIENT BUT NOT YET RUNNING AND THEN BEGINNING TO BACKPRIME, I DISCOVERED A CUT IN THE SECONDARY TUBING WHEN THE SALINE BEGAN SPILLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500899 ↗
• MalfunctionMar 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD SECONDARY ADMINISTRATION SET SEPARATED RIGHT BELOW THE DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SECONDARY TUBING WAS BEING PREPARED BY A NURSE THIS MORNING AND THE TUBING CAME APART RIGHT BELOW THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500885 ↗