Alaris 8110 (UDI 10885403811043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,299 adverse event reports that list this exact device (DI 10885403811043), received between Jan 25, 2022 and Sep 9, 2026 — classified as 10 injuries, 4,289 malfunctions.

The most frequently reported specific device problem is “Break” (1,803 reports).

2 FDA recall records name this device's identifier, 2 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. Aug 15, 2024Class IIOpen, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3141-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 15, 2023Class IOpen, Classified

   Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

   Z-0185-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,299 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Excess Flow or Over-Infusion

  It was reported that a pediatric ICU patient was noted at the start of shift to be significantly less responsive than on prior days despite decreasing sedation in preparation for extubation. The nurse stopped the morphine infusion and later dexmedetomidine and subsequently observed that the morphine syringe contained far less medication than expected. Clinical findings, including decreased responsiveness, urinary retention, rising CO2 levels, ventilator support requirements, constricted pupils, and reduced cough strength, were consistent with opioid toxicity. Although naloxone was initially deferred, administration of 0.05 mg naloxone later that day resulted in immediate improvement in alertness, eye tracking, responsiveness, and cough/gag reflexes, confirming opioid effect as the likely cause of the altered mental status.Biomedical Engineering investigated the Syringe Infusion Pump Module and found no pump programming errors, alarms, or equipment faults. A cracked morphine syringe was identified, with the defect located beneath the syringe label and difficult to detect visually. Customer testing demonstrated that air could enter through the crack, allegedly allowing medication to

  Patient problems: Decreased Level of Consciousness

  MAUDE report 50685190 ↗
• MalfunctionJul 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25872774 ↗
• MalfunctionJul 15, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25823548 ↗
• MalfunctionJul 13, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25793746 ↗
• MalfunctionJul 10, 2026Break; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25778805 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761223 ↗
• MalfunctionJul 9, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761220 ↗
• MalfunctionJul 3, 2026Naturally Worn

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703647 ↗
• MalfunctionJun 17, 2026Pumping Stopped; No Apparent Adverse Event

  IT WAS REPORTED THAT THREE PUMPS INVOLVED IN AN INCIDENT AND THE ENTIRE SET SHUT DOWN ON ITS OWN. THE PATIENT WAS RECEIVING AN INFUSION OF HEPARIN (1UNIT/ML IN 0.45% NACL) AT A RATE OF 1ML / HOUR THE EVENT OCCURRED BETWEEN 2300-0100 HOURS. THE DEVICES WERE PLUGGED INTO AC POWER AT THE TIME OF THE EVENT. PICC LINE WAS FLUSHED AND SUBSEQUENTLY HAD TO BE REPLACED BUT NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530731 ↗
• MalfunctionJun 16, 2026Inaccurate Delivery; No Apparent Adverse Event

  IT WAS REPORTED THAT THE ALARIS SYRINGE PUMP MODULE ADMINISTERING CONTINUOUS ALPROSTADIL INFUSION REPEATEDLY ALARMED FOR ¿PATIENT OCCLUSION,¿ WITH INCONSISTENT DOCUMENTED INFUSION VOLUMES (0.06ML AT 8PM, 0.09ML AT 9PM, AND A DECREASED VOLUME OF 0.08ML AT 10PM), LIKELY RELATED TO FREQUENT INTERRUPTIONS FROM OCCLUSION ALARMS ON (B)(6) 2026. AFTER SWITCHING TO A DIFFERENT SYRINGE PUMP, THE INFUSION VOLUMES WERE ACCURATE. BIOMED EVALUATED THE RETURNED SYRINGE ONLY (P119377), AS THE PCU AND TUBING WERE UNAVAILABLE, AND WAS ABLE TO REPLICATE DECREASING VOLUME READINGS WHEN OCCLUSION ALARMS WERE CLEARED WITHOUT RESOLVING THE OCCLUSION. CUSTOMER REPORTED "MINOR HARM, AS THE PATIENT MAY HAVE RECEIVED LESS ALPROSTADIL THAN WHAT WAS TRACKED BY THE PUMP". NO FURTHER INFORMATION WAS MADE AVAILABLE. CUSTOMER BIOMED HAS PERFORMED INVESTIGATION ON THE DEVICE. PCU AND LINES WERE NOT ABLE TO BE SET ASIDE. CUSTOMER ABLE TO REPLICATE THE DECREASING VOLUME WHEN THE PUMP OCCLUSION ALARM IS CLEARED WITHOUT CLEARING THE OCCLUSION. DEVICES WILL NOT BE SENT TO BD FOR INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 25521552 ↗
• MalfunctionJun 16, 2026Display or Visual Feedback Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS RECEIVING PROSTIN VIA A PICC LINE USING A SYRINGE PUMP MODULE (CHANNEL C) WHEN A DISCREPANCY IN INFUSION VOLUME WAS NOTED. AFTER RESETTING THE ¿VOLUME INFUSED¿ TO TRACK HOURLY DELIVERY, THE RN OBSERVED 0.05ML INFUSED AT ~0920 BEFORE GOING ON A BREAK. UPON RETURN AT 1000, THE VOLUME INFUSED DISPLAY WAS BLANK DESPITE THE PUMP INDICATING THE INFUSION WAS ONGOING, PREVENTING CONFIRMATION OF DELIVERED MEDICATION. AT ~1030, THE DISPLAY REAPPEARED BUT SHOWED 0ML INFUSED, LEAVING THE AMOUNT ADMINISTERED DURING THAT PERIOD UNKNOWN. THE PUMP FUNCTIONED NORMALLY AGAIN AFTER 1100 BUT WAS REPLACED DUE TO SAFETY CONCERNS. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM. BIOMED RECEIVED THE PCU AND LATER IDENTIFIED THE ASSOCIATED SYRINGE PUMP MODULE, THOUGH NO SYRINGE OR TUBING WAS AVAILABLE FOR EVALUATION. THE ISSUE COULD NOT BE REPLICATED, AND INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521547 ↗
• MalfunctionJun 15, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE PLUNGER HAS RETURNED TO BEING STUCK/STICKY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508103 ↗
• MalfunctionMay 22, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE HAD PLUNGER FORCE ACCURACY FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252381 ↗
• MalfunctionMay 18, 2026Accessory Incompatible; Use of Device Problem; Insufficient Flow or Under Infusion; Naturally Worn

  IT WAS REPORTED THAT THE SYRINGE PUMP ALARMED MULTIPLE TIMES AND EVENTUALLY DISPLAYED A GLITCH SCREEN. AS A RESULT, THE NURSING STAFF WERE UNABLE TO DETERMINE HOW MUCH VOLUME HAD BEEN INFUSED TO THE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: PC UNIT USED DURING THE INCIDENT WAS IDENTIFIED FROM NICU EVENT AND ERROR LOGS DOWNLOADED FOR BOTH PCU AND SYRINGE MODULE. NO RELEVANT ERRORS IDENTIFIED IN THE ERROR LOGS FOR EITHER DEVICE. PCU EVENT LOGS REVIEWED BY HOSPITAL BIOMED: DRUG: ALPROSTADIL , RATE: 1.39 ML/H, DRUG AMOUNT: 5 MCG, DILUENT VOLUME: 1 ML , CONCENTRATION: 5 MCG/ML , DOSE: 0.03 MCG/KG/MIN , PATIENT WEIGHT: 3.86 KG , TIME UNITS: MINUTES , SYRINGE TYPE: BD 50 ML. EVENT LOG REVIEW SHOWED: O BETWEEN 01:00 04:00, THE INFUSOR STOPPED AND ALARMED APPROXIMATELY 8 TIMES PRIOR TO TUBING REPLACEMENT. TUBING REPLACEMENT RECORDED AT 03:13. CHANNEL TURNED OFF AT 03:54. EACH ALARM WAS FOLLOWED BY PUMP RESTART AND REPROGRAMMING. RECORDED VOLUME INFUSED VALUES WERE INCONSISTENT AND DECREASED ACROSS EVENTS, INDICATING UNRELIABLE VOLUME TRACKING, LIKELY DUE TO REPEATED RESTARTS/REPROGRAMMING. EVENT SEQUENCES SHOW THE PUMP WAS REPEATEDLY RESTARTED IMMEDIATELY AFTER OCCLUSION ALA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211754 ↗
• MalfunctionMay 13, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE HAD FAILED BARREL CLAMP OPEN TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158711 ↗
• MalfunctionMay 13, 2026Break; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD BAD MOTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158700 ↗
• MalfunctionMay 13, 2026Break; Contamination; Output Problem

  IT WAS REPORTED THAT THE DEVICE HAD BAD MOTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158257 ↗
• MalfunctionMay 13, 2026Break; Circuit Failure; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD DRIVE ARM MOVING FREELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157836 ↗
• MalfunctionMay 6, 2026Calibration Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD DEFECTIVE BARREL CLAMP THAT IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092579 ↗
• MalfunctionApr 27, 2026Break; Loose or Intermittent Connection; Deformation Due to Compressive Stress; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE HAD RATTLING INTERNALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998502 ↗
• MalfunctionApr 24, 2026Break; Deformation Due to Compressive Stress; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE HAD FAILED PLUNGER FORCE CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979566 ↗
• MalfunctionApr 21, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938551 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906744 ↗
• MalfunctionApr 6, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788617 ↗
• MalfunctionApr 6, 2026Break; Contamination

  IT WAS REPORTED THAT THE DEVICE HAD CRACKED FRONT CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788556 ↗