Alaris 8015 (UDI 10885403801549)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13,022 adverse event reports that list this exact device (DI 10885403801549), received between Mar 2, 2022 and Sep 23, 2026 — classified as 6 deaths, 32 injuries, 12,984 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (5,126 reports).

3 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 15, 2024Open, 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-3138-2024 · Root cause: Process control · FDA record ↗

2. Sep 15, 2023Open, Classified

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

   Z-0186-2024 · Root cause: Under Investigation by firm · FDA record ↗

3. Jan 24, 2023Open, Classified

   Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

   Z-1192-2023 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 13,022 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Battery Problem

  It was reported that the device had failed battery conditioning. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870760 ↗
• MalfunctionSep 22, 2026Inaccurate Delivery

  It was reported that the patient was receiving a continuous bivalirudin infusion that was ordered to run at 0.158 mg/kg/hr. The infusion was started at the correct rate 0.158 mg/kg/h (12.6 mL/hr) via interoperability. It was later discovered running at the incorrect rate of 0.1593 mg/kg/hr (12.7 mL/hr) for approximately two hours starting at 5:41AM. There was patient involvement and no harm.Additional information provided 02SEP2026: Per review of the event logs, it appears that the clinician inadvertently pressed the "Up Arrow" key prior to pressing start at 05:41:17. This increased the rate from 12.6 mL/hr to 12.7 mL/hr.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850121 ↗
• MalfunctionSep 15, 2026Inadequate or Insufficient Training

  It was reported that the 8015 Defective battery. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768175 ↗
• MalfunctionSep 8, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672945 ↗
• MalfunctionSep 3, 2026Device Alarm System

  It was reported that the device had error 255-20-22 during battery reconditioning. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50593002 ↗
• MalfunctionSep 3, 2026Device Alarm System

  It was reported that the device had error 255-20-22 during battery reconditioning. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589599 ↗
• MalfunctionSep 3, 2026Device Alarm System

  It was reported that the device had error 255-20-22 during battery reconditioning. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589594 ↗
• MalfunctionSep 2, 2026Device Alarm System

  It was reported that the device had error code 133.6090. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568103 ↗
• MalfunctionAug 19, 2026Battery Problem

  Patient problems: Insufficient Information

  MAUDE report 50315365 ↗
• MalfunctionAug 14, 2026Break; Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251017 ↗
• MalfunctionAug 14, 2026Contamination; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251011 ↗
• InjuryAug 14, 2026Inaccurate Delivery

  It was reported that there was an event where a patient was receiving a continuous intravenous heparin infusion experienced an unintended rapid infusion event. The heparin infusion was ordered and programmed to run at 1,150 units/hour in accordance with the established heparin protocol.A new heparin bag was initiated at 1214 hours following independent dose and rate verification by two registered nurses using the patient¿s most recent PTT result. The infusion pump was programmed to deliver heparin at 1,150 units/hour.During the scheduled infusion check at 1315 hours, nursing staff noted the heparin bag was nearly empty despite the prescribed infusion rate. The pump alarmed at this time, and the infusion was immediately stopped. A second nurse independently reviewed the pump programming and confirmed that the programmed settings were correct.The patient was assessed immediately following identification of the event. No signs or symptoms of bleeding were present, and vital signs remained stable. The responsible medical team, charge nurses, and unit manager were notified. The heparin infusion was held, and urgent coagulation studies were obtained. Protamine 100 mg IV was administered

  Patient problems: Insufficient Information

  MAUDE report 50249313 ↗
• MalfunctionAug 13, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233234 ↗
• MalfunctionAug 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192968 ↗
• MalfunctionAug 7, 2026Device Alarm System; Circuit Failure; Corroded; Application Program Problem; Computer Operating System Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169534 ↗
• MalfunctionJul 30, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082969 ↗
• MalfunctionJul 29, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068946 ↗
• MalfunctionJul 29, 2026Device Alarm System; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067059 ↗
• MalfunctionJul 27, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022072 ↗
• MalfunctionJul 27, 2026Premature Discharge of Battery

  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 50021934 ↗
• MalfunctionJul 6, 2026Break; Display or Visual Feedback 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 25716023 ↗
• MalfunctionJul 2, 2026Display or Visual Feedback 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 25689685 ↗
• MalfunctionJul 2, 2026Break; Contamination

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED FOR THE REPORTED FAILURE AS IT WAS OBSERVED BY THE MANUFACTURER DURING SERVICING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689240 ↗
• MalfunctionJul 2, 2026Battery Problem

  IT WAS REPORTED THAT THE DEVICE HAD WILL NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687836 ↗
• MalfunctionJul 1, 2026Contamination

  IT WAS REPORTED THAT THE DEVICE HAD 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 25676562 ↗