Alaris 8120 (UDI 10885403812033)Recalls & reported problems

Summary

The FDA's MAUDE database contains 950 adverse event reports that list this exact device (DI 10885403812033), received between Jul 21, 2022 and Sep 14, 2026 — classified as 2 deaths, 4 injuries, 944 malfunctions.

The most frequently reported specific device problem is “Break” (473 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-3139-2024 · 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-0184-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 950 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Contamination; Corroded

  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 50749826 ↗
• MalfunctionSep 4, 2026Circuit Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614082 ↗
• MalfunctionJul 9, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 351.666. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25759545 ↗
• MalfunctionJun 25, 2026Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE 8120 IS SHOWING CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617651 ↗
• MalfunctionJun 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PUMP ALARMED BEFORE THE INFUSION. THE CLINICIAN OBSERVED THAT THE INFUSED VOLUME WAS 48 ML. HOWEVER, AFTER POWERING THE DEVICE OFF AND TURNING IT BACK ON, THE INFUSED VOLUME DISPLAYED WAS 51ML. DEVICES WERE SUBSEQUENTLY REMOVED FROM THE OPERATION AREA. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408164 ↗
• MalfunctionMay 19, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 351.6660. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25213192 ↗
• MalfunctionApr 29, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR, FORCE SENSOR OR LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25026789 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAD SYRINGE NOT DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996610 ↗
• MalfunctionApr 22, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. FORCE SENSOR OR LOGIC CARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951756 ↗
• MalfunctionApr 21, 2026Corroded; Device Markings/Labelling Problem

  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.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940416 ↗
• MalfunctionApr 3, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR 351.660 PUMP JUST RETURNED FROM BD DEPOT REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774074 ↗
• MalfunctionMar 20, 2026Failure to Read Input Signal

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646741 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAD DOSE CORD UNRESPONSIVE / UNIT NOT RECOGNIZING THE DOSE CORD. THERE WAS NO PATIENT INVOLVEMENT.AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637787 ↗
• MalfunctionMar 17, 2026Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE DEVICE HAD 351.6660 ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616666 ↗
• MalfunctionMar 13, 2026Break; Deformation Due to Compressive Stress; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589464 ↗
• MalfunctionMar 13, 2026Break; Device Markings/Labelling Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588932 ↗
• MalfunctionMar 13, 2026Break; Contamination

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588862 ↗
• MalfunctionMar 9, 2026Device Alarm System

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: ¿CHANNEL ERROR." ADDITIONAL NOTES PROVIDED BY THE FACILITY¿S CLINICAL ENGINEERING SUPPORT SERVICES INCLUDE: "CLUTCH TAKEN APART AND LUBRICATED. NO OTHER ISSUES NOTED." REPORTED PROBLEM CAUSE DESCRIPTION: "MECHANICAL - ELECTRICAL." THERE WAS NO REPORTED PATIENT INVOLVEMENT. ALTHOUGH ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN PREVIOUSLY REQUESTED, THE CUSTOMER PROVIDED A GENERAL STATEMENT THAT ¿NO FURTHER INFORMATION WILL BE PROVIDED, INCLUDING PATIENT DEMOGRAPHICS AND NO PRODUCTS WILL BE RETURNED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542762 ↗
• MalfunctionMar 6, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: ¿CHANNEL ERROR." ADDITIONAL NOTES PROVIDED BY THE FACILITY¿S CLINICAL ENGINEERING SUPPORT SERVICES INCLUDE: "L IUI REPLACED. CHECK IN COMPLETED WITHOUT ISSUES.."REPORTED PROBLEM CAUSE DESCRIPTION: "MECHANICAL - ELECTRICAL."THERE WAS NO REPORTED PATIENT INVOLVEMENT. ALTHOUGH ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN PREVIOUSLY REQUESTED, THE CUSTOMER PROVIDED A GENERAL STATEMENT THAT ¿NO FURTHER INFORMATION WILL BE PROVIDED, INCLUDING PATIENT DEMOGRAPHICS AND NO PRODUCTS WILL BE RETURNED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530422 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: ¿NO NOTE." ADDITIONAL NOTES PROVIDED BY THE FACILITY¿S CLINICAL ENGINEERING SUPPORT SERVICES INCLUDE: "CHECK IN COMPLETED. NEW RIGHT SIDE IUI." REPORTED PROBLEM CAUSE DESCRIPTION: "MECHANICAL - ELECTRICAL." THERE WAS NO REPORTED PATIENT INVOLVEMENT. ALTHOUGH ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN PREVIOUSLY REQUESTED, THE CUSTOMER PROVIDED A GENERAL STATEMENT THAT ¿NO FURTHER INFORMATION WILL BE PROVIDED, INCLUDING PATIENT DEMOGRAPHICS AND NO PRODUCTS WILL BE RETURNED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24467879 ↗
• MalfunctionFeb 13, 2026Break; Corroded; Deformation Due to Compressive Stress; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE HAD FAILED FORCE ACCURACY TEST AND CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331896 ↗
• MalfunctionFeb 4, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAD 353.666. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256037 ↗
• MalfunctionJan 28, 2026Crack

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: ¿ALARIS PCA." ADDITIONAL NOTES PROVIDED BY THE FACILITY¿S CLINICAL ENGINEERING SUPPORT SERVICES INCLUDE: " REPLACED IUI CONNECTOR AND RAN THROUGH PM PROCEDURE ON THE ALARIS SOFTWARE." REPORTED PROBLEM CAUSE DESCRIPTION: "MECHANICAL - ELECTRICAL." THERE WAS NO REPORTED PATIENT INVOLVEMENT. ALTHOUGH ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN PREVIOUSLY REQUESTED, THE CUSTOMER PROVIDED A GENERAL STATEMENT THAT ¿NO FURTHER INFORMATION WILL BE PROVIDED, INCLUDING PATIENT DEMOGRAPHICS AND NO PRODUCTS WILL BE RETURNED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197135 ↗
• MalfunctionJan 23, 2026Use of Device Problem; Inaccurate Delivery

  IT WAS REPORTED THAT THE PATIENT CONTROLLED ANALGESIA PUMP MODULE WAS PROGRAMMED FOR A CONTINUOUS INFUSION OF HYDROMORPHONE AT 0.4MG/HR, IN ADDITION TO A BOLUS OF 0.2MG. HOWEVER, THE MD ORDER SPECIFIED 0MG FOR THE CONTINUOUS INFUSION. THE CUSTOMER ALSO NOTED THAT THE INCIDENT WAS "ALREADY CLEARED" BASED ON THE INFUSION PROVIDED BUT, "IT SEEMS THAT THERE MAY HAVE BEEN AN ISSUE WITH HOW THE PCA PUMP WAS PROGRAMMED (POSSIBLY OPERATOR ERROR), LEADING TO A DISCREPANCY BETWEEN THE MD ORDER AND THE PUMP SETTINGS." THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159010 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: ¿BROKEN PCA CABLE." ADDITIONAL NOTES PROVIDED BY THE FACILITY¿S CLINICAL ENGINEERING SUPPORT SERVICES INCLUDE: "I REPAIRED THE CORD AND TESTED."REPORTED PROBLEM CAUSE DESCRIPTION: "INCIDENTAL."THERE WAS NO REPORTED PATIENT INVOLVEMENT. ALTHOUGH ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN PREVIOUSLY REQUESTED, THE CUSTOMER PROVIDED A GENERAL STATEMENT THAT ¿NO FURTHER INFORMATION WILL BE PROVIDED, INCLUDING PATIENT DEMOGRAPHICS AND NO PRODUCTS WILL BE RETURNED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158197 ↗