BD Alaris™ PCU Module, Model 8015 (REF 8015BDMDXEN1213)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403515231), received between Jan 30, 2024 and Apr 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (2 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 16, 2026.

Recalls naming this device

1. Feb 11, 2026Open, Classified

   Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

   Z-1645-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Contamination; Corroded

  IT WAS REPORTED THAT THE CUSTOMER HAD REQUESTED A LOG REVIEW OF THE PCU EVENT LOGS. THE CUSTOMER WOULD LIKE TO SEE THE EVENT LOGS DATED FROM (B)(6). THERE WAS PATIENT INVOLVEMENT BUT NO HARM. THE CUSTOMER HAD THE FOLLOWING QUESTION/INQUIRY: "WE WOULD LIKE TO KNOW WHY THE EVENT LOGS FROM (B)(6) 2026, ARE MISSING? ONLY THE EVENT LOGS FROM (B)(6) ARE REGISTERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812373 ↗
• MalfunctionMay 22, 2024Crack; Crack

  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 19373601 ↗
• MalfunctionMar 8, 2024Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  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 18863976 ↗
• MalfunctionFeb 15, 2024Circuit Failure; Battery Problem; Circuit Failure; Battery 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 18714078 ↗
• MalfunctionJan 30, 2024Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON A CHANNEL ON THE RIGHT SIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605176 ↗