Plum 360 300100413Recalls & reported problems

Icu Medical, Inc. · Plum 360 Infuser · Class 2

All models of Plum 360 (3)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M3353001004131), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K161469); 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Application Program Problem: Dose Calculation Error1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 7, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT A PLUM 360 EXPERIENCED AN INFUSION DOSAGE CHANGE DURING PATIENT USE. THE REPORT STATED THAT WHEN THE CUSTOMER PAUSED THE PUMP AND THEN RESUMED, THE PUMP CHANGED THE DOSAGE. THE REPORTED ISSUE WAS NOT RELATED TO PHYSICAL DAMAGE. THERE WAS PATIENT INVOLVEMENT, NO HARM, AND A DELAY IN THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19933715 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161469. One submission often covers many models, so check the product and lot details in each record.

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-0171-2020 · Aug 1, 2018 · Terminated
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Z-0101-2018 · Oct 30, 2017 · Terminated
Plum 360 Infusion System, List number 30010.
Z-3031-2017 · Jun 15, 2017 · Terminated
Plum 360 Infusion System

Device details

UDI-DI	`M3353001004131`
Brand	Plum 360
Model	300100413
Catalog no.	30010
Company	Icu Medical, Inc.
Product code	FRN · Pump, infusion
Class	Class 2
FDA submission	K161469
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 4, 2022

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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