Plum 2079225Recalls & reported problems

ICU Medical, Inc. · Plum A+ Version 13.43 w/MedNet · Class 2

All models of Plum (26)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M3352079204251), received between Aug 29, 2017 and Aug 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Infusion or Flow Problem2
Device Sensing Problem1
Excess Flow or Over-Infusion1
Inaccurate Flow Rate1
Smoking1

Patient problems

No Consequences Or Impact To Patient2
No Clinical Signs, Symptoms or Conditions1
No Patient Involvement1

Recent adverse event reports

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

MalfunctionAug 20, 2024Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate; Infusion or Flow Problem
THE COMPLAINT/EVENT INVOLVED A PLUM A+ (11.3 VERSION) NEW RESTART. IT WAS REPORTED THAT A POTASSIUM CHLORIDE DRIP WAS INSTALLED (NOT LABELED ON THE PUMP). A TOTAL VOLUME OF 500 ML WAS INSTALLED AT 40 CC/H, AND IT WAS REPORTED THAT IN 01 HOUR THE TOTAL VOLUME OF 500 ML WAS INFUSED. THIS OCCURED BETWEEN 9:00 P.M. AND 12:00 A.M. THE INFIRMARY REPORTED THAT THE INFUSION RATE WAS DISPLAYED AT 47 CC/H. THE MESSAGE "CASSETTE ERROR" WAS DISPLAYED, BUT SUBSEQUENTLY OTHER MEDICATIONS CONTINUED TO BE INFUSED, FOR WHICH NO MESSAGE WAS DISPLAYED. THERE WAS NO CLINICAL ALTERATION IN THE PATIENT AFTER THE EVENT AND UNSPECIFIED PERTINENT MEASURES WERE TAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006413 ↗
MalfunctionMay 5, 2020Infusion or Flow Problem; Infusion or Flow Problem
THIS IS A GENERAL COMPLAINT OF UNSPECIFIED PLUM A+ PUMPS THAT ON UNKNOWN DATES, WERE REPORTED TO HAVE ISSUES WITH AIR GETTING INTO THE CHAMBER AND NOT ALARMING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10025947 ↗
MalfunctionDec 11, 2019Excess Flow or Over-Infusion; Device Sensing Problem; Excess Flow or Over-Infusion; Device Sensing Problem
THE EVENT INVOLVED A PLUM A+ PUMP THAT WAS REPORTED TO BE OVER INFUSING AND DID NOT AUDIBLY ALARM FOR AIR IN LINE. THE DEVICE WAS REPORTED TO DELIVER 50 MLS FASTER THAN IT SHOULD HAVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9449724 ↗
MalfunctionAug 29, 2017Smoking; Smoking
THE CUSTOMER REPORTED THE DEVICE HAD A SMOKE PHENOMENON. TESTING AND INVESTIGATION CONFIRMED THE SMOKE PHENOMENON AND FOUND THAT THE POWER SUPPLY WAS BURNT AND REQUIRED REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6827673 ↗

Device details

UDI-DI	`M3352079204251`
Brand	Plum
Model	2079225
Catalog no.	20792
Company	ICU Medical, Inc.
Product code	FRN · Pump, infusion
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 17, 2025

Device type (GMDN): Bedside infusion pump, single-channel

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

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All Pump, infusion devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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