ICU Medical 14018-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887709101842), received between Feb 1, 2024 and Sep 16, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 reports).

11 other recalls cover devices cleared under the same FDA submission (K141789); they may or may not involve this specific model.

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.

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.

• MalfunctionSep 16, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794949 ↗
• MalfunctionJun 15, 2026Contamination

  AN EVENT OCCURRED ON AN UNSPECIFIED EVENT DATE INVOLVING A IV TUBING SET REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS FOUND INSIDE THE DRIP CHAMBER AND ALSO FOUND INSIDE THE AREA WHERE THE DRIP CHAMBER WAS NARROWED INTO THE TUBING AS WELL AS THE SMALLER CHAMBER JUST ABOVE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500231 ↗
• MalfunctionJun 15, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH, AND IT WAS REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS FOUND INSIDE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT, AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499138 ↗
• MalfunctionJun 15, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH, AND IT WAS REPORTED THAT THERE WAS A RANGE OF BLACK AND BROWN DOTS FOUND INSIDE THE DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499131 ↗
• MalfunctionFeb 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH. IT WAS REPORTED THAT THE FACILITY WAS HAVING ISSUES WITH LEAKING FROM THE DEVICE'S POP-OPEN VALVE NEAR THE TOP OF THE TUBING. THE TUBING SET UP WAS A STANDARD STERILE PROCEDURE/PROCESS FOR SPIKING THE TOTAL PARENTERAL NUTRITION (TPN) BAG AND CONNECTING THE IV FLUID/CONNECTORS TO THE PATIENT LINE. THE TUBING WAS REPLACED AND THEY NEEDED TO SWITCH TO AN ALTERNATE FLUID BECAUSE REPLACEMENT TPN COULD NOT BE MADE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18626467 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141789. One submission often covers many models, so check the product and lot details in each record.

• Z-3162-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-2447-2024 · May 7, 2024 · Open, Classified
  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following de
• Z-2430-2023 · Jul 13, 2023 · Open, Classified
  Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 3001010
• Z-1565-2023 · Mar 22, 2023 · Open, Classified
  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
• Z-0127-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Line
• Z-0128-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Mic
• Z-0145-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Mic
• Z-3031-2017 · Jun 15, 2017 · Terminated
  Plum 360 Infusion System
• Z-1682-2017 · Dec 30, 2016 · Terminated
  Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
• Z-1832-2016 · Mar 25, 2016 · Terminated
  The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver
• Z-1833-2016 · Mar 25, 2016 · Terminated
  The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With it