Alaris 2232-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885403463969), received between Feb 21, 2019 and Feb 11, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Recalls naming this device

1. Sep 11, 2025Class IOpen, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT IV PUMP KEPT BEEPING AIR IN LINE FOR TUBING THAT HAD NO AIR. RN TRIED MULTIPLE TIMES TO RESET TUBING, SWITCHED PUMPS STILL AIR IN LINE MESSAGE OCCURRED. RN HAD TO CHANGE OUT ALL THE IV TUBING FOR IT TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354802 ↗
• MalfunctionOct 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935227 ↗
• MalfunctionSep 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD GEM V/NV 20D 0.2 FLTR WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: RN WAS SETTING UP HER IV TUBING WHEN THE PRIMING FLUIDS WOULDN'T MOVE THROUGHOUT THE TUBING. THE TUBING WAS UNCLAMPED. THE FLUID WAS NOT MOVING THROUGH THE IV TUBING DESPITE BEING UNCLAMPED. RN CALLED HER CHARGE NURSE, RN TO EVALUATE AND SAID THAT THE TUBING MAY HAVE BEEN DEFECTIVE SINCE IT WAS NOT MOVING DESPITE BEING UNCLAMPED. UNABLE TO PRIME PUMP INFUSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738323 ↗
• MalfunctionApr 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 OF THE BD ALARIS¿ LVP GEM V/NV 20D 0.2 FLTR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709370 ↗
• MalfunctionJul 28, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A LIPID TUBING THAT WAS ABLE TO BE PRIMED BUT WOULD NOT INFUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127322 ↗
• MalfunctionDec 8, 2021Leak/Splash; Chemical Problem; Leak/Splash; Chemical Problem

  IT WAS REPORTED THAT THE BD GEM V/NV 20D 0.2 FLTR EXPERIENCED AIR IN LINE, AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTED NEW LARGE BORE IV TUBING TO PATIENT PIV. PUMP ALARMED AIR IN LINE. WHEN I OPENED UP IV CHANNEL AND GENTLY TOOK OUT TUBING TO CHECK THE "AIR", THE TUBING CAME APART AND FLUIDS WENT EVERYWHERE. TUBING WAS HUNG EARLIER THAT SAME DAY. NO OTHER TREATMENT OF FOLLOW-UP WAS NECESSARY OUTSIDE OF GETTING NEW TUBING SET UP. THE DEFECTIVE PRODUCT HAS BEEN SAVED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12959818 ↗
• MalfunctionJul 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GEM V/NV 20D 0.2 FLTR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PT'S METHOTREXATE LINE WAS LEAKING FROM THE FILTER (SPECIFICALLY THE SMALL DOTS ON THE BACK OF THE FILTER). PATIENT AND MOM NOTICED VERY SMALL LIME GREEN DOTS ON BED SHEET (PT DID NOT COME IN CONTACT WITH THE METHOTREXATE). AFTER DISCUSSING WITH PHARMACY, FAMILY AND THE CHARGE NURSE, WE DECIDED THE BEST THING TO DO WOULD BE TO WRAP THE FILTER (TEGADERM THEN WRAPPED WITH GAUZE AND COBAN), AND LET THE METHOTREXATE FINISH (THERE WAS ONLY 1.5 HRS LEFT OF 24 HR METHOTREXATE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199824 ↗
• InjuryMay 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GEM V/NV 20D 0.2 FLTR TUBING BROKE OFF FROM FILTER AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 2232-0007. BATCH NO.: UNKNOWN. IT WAS REPORTED THE TUBING BROKE OFF FROM THE FILTER. 15 MONTH OLD PATIENT BROKE IV TUBING AT MICRON FILTER EXTENSION WHICH LED TO BLOOD FLOWING OUT OF BROKEN LINE FROM CENTRAL LINE IN HALF HOUR BETWEEN 0800 ROUNDING AND NURSE CHECKING IN AT 0830. AS A RESULT OF THIS BLOOD LOSS PATIENT REQUIRED A CLAVE CHANGE ON LINE AND DRESSING CHANGE, NEITHER OF WHICH WOULD HAVE BEEN REQUIRED FOR SEVERAL DAYS. THIS SIGNIFICANTLY INCREASED PATIENT'S INFECTION RISK DURING COUNT. PATIENT ALSO REQUIRED A CBC TO BE DRAWN WHICH SHOWED A NOTEWORTHY DROP IN HEMOGLOBIN AND HEMATOCRIT, NEARLY CAUSING PATIENT TO REQUIRE BLOOD TRANSFUSION.

  Patient problems: Anemia

  MAUDE report 11829352 ↗
• MalfunctionApr 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GEM V/NV 20D 0.2 FLTR TUBING RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2232-0007 BATCH/LOT #: UNKNOWN IT WAS REPORTED THAT THERE IS A SMALL HOLE/SLIT IN THE TUBING. VERBATIM: IV TUBING PRIMED WITH FLUIDS AND HOOKED UP TO PATIENT. NURSE NOTICED A PUDDLE ON THE FLOOR UNDER IV PUMP. IV PUMP WAS DRIPPING FLUID OUT OF IV PUMP CHANNEL. NURSE CHANGED IV TUBING AND NOTICED THAT THERE IS A SMALL HOLE/SLIT IN THE TUBING. IV TUBING SAVED FOR REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697846 ↗
• MalfunctionNov 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GEM V/NV 20D 0.2 FLTR LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2232-0007, BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THERE IS LEAKAGE COMING FROM THE FILTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10849169 ↗
• MalfunctionMay 18, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE TUBING SET SEPARATED AT THE ENGAGEMENT OF THE PUMP SEGMENT TO THE LOWER FITMENT AND LEAKED WHILE INFUSING TOTAL PARENTERAL NUTRITION (TPN). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 10064390 ↗
• MalfunctionApr 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SET SEPARATED AT THE FILTER WHEN TAKEN OUT OF THE PACKAGE FOR PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9926095 ↗
• MalfunctionFeb 6, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING SET WAS FOUND TO HAVE A HOLE IN IT DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9678609 ↗
• MalfunctionDec 16, 2019Backflow; Physical Resistance/Sticking; Backflow; Physical Resistance/Sticking

  IT WAS REPORTED FROM THE (ICS THAT WHEN THE NURSE DISCONNECTED THE TUBING SET FROM THE PATIENT'S PERIPHERAL IV, THE END OF THE TUBING SET BECAME "STUCK" IN THE "CLAVE", AND THE PATIENT'S BLOOD BEGAN TO BACK-UP INTO THE LINE. THE TUBING SET CONNECTOR AND "CLAVE" WERE CHANGED. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE CHILD PATIENT FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9476939 ↗
• MalfunctionSep 25, 2019Backflow; Backflow

  IT WAS REPORTED THAT THE NORMAL SALINE INFUSION KEPT BACKING UP DURING THE EPINEPHRINE, NOREPINEPHRINE AND NORMAL SALINE FLUSH INFUSIONS WHICH PREVENTED ACCURATE AND TIMELY DELIVERY OF THE NECESSARY MEDICATIONS. THE TUBING SET WAS CHANGED TO A NON-FILTERED TUBING SET AND THE MEDICATIONS INFUSED WITHOUT FURTHER DIFFICULTY. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL PATIENT OR EVENT INFORMATION AVAILABLE.

  Patient problems: No Information

  MAUDE report 9121087 ↗
• MalfunctionSep 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE TUBING SET FILTER LEAKED DURING A METHOTREXATE INFUSION WITH AN APPROXIMATED 25CC'S OF MEDICATION LOST DURING USE ON A PEDIATRIC PATIENT. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Information

  MAUDE report 8967157 ↗
• MalfunctionAug 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RN FOUND THE TUBING SET FILTER LEAKING DURING PATIENT USE. THE TUBING SET WAS CLEANED AND DRIED TO FIND THAT IT CONTINUED TO LEAK WITH NO VISIBLE CRACKS FOUND IN THE FILTER. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE CHILD PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893040 ↗
• MalfunctionApr 12, 2019Fracture; Leak/Splash; Fracture; Leak/Splash

  THE CUSTOMER REPORTED THAT THE TUBING SET FILTER CRACKED AND LEAKED DURING A METHOTREXATE INFUSION ON A PEDIATRIC PATIENT. THE CUSTOMER REPORTED NO PATIENT HARM BUT NOTED THERE WAS AN INCREASED RISK OF INFECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8511908 ↗
• MalfunctionFeb 21, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT THE PEDIATRIC DEPARTMENT EXPERIENCED A LARGE BORE IV TUBING SET THAT SEPARATED AND LEAKED BELOW THE FILTER DURING PATIENT USE. THE TUBING SET WAS REPLACED WITH A NEW SET. OTHER THAN THE INCREASED RISK OF INFECTION DUE TO THE TUBING SET REQUIRING TO BE REPLACED, THERE WAS NO PATIENT HARM CAUSED BY THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360495 ↗