ICU MEDICAL INC

MedNet · Anesthesiology

510(k): 0 Recall: 4 UDI: 4 MAUDE: 2 Class.: 59

Recalls (4)

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 descriptions: Bomba de infusin Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360,

2024-05-07

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PL

2024-05-07

Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

2018-08-01

A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.

ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communicat

2017-10-30

Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2…

UDI Registrations (4)

MedNet

Metnet Software

ICU Medical MedNet

Mednet Software

ICU Medical MedNet

Mednet Software

ICU Medical MedNet

Mednet Software

MAUDE Adverse Events (2)

Malfunction

20230424

Untitled record

FDA Classification (59)

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Anesthesiology

Humidifier, Respiratory Gas, (Direct Patient Interface)

Anesthesiology

Anesthesia Conduction Kit

Anesthesiology

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Anesthesiology

High Flow/High Velocity Humidified Oxygen Delivery Device

Anesthesiology

Monitor, Carbon-Dioxide, Cutaneous

Anesthesiology

Plethysmograph, Pressure

Anesthesiology

Caudal Anesthesia Kit

Anesthesiology

Regulator, Pressure, Gas Cylinder

Anesthesiology

Bag, Reservoir

Anesthesiology

Brush, Cleaning, Tracheal Tube

Anesthesiology

Analyzer, Nitrogen Dioxide

Anesthesiology

Algesimeter, Powered

Anesthesiology

Ventilatory Effort Recorder

Anesthesiology

Adjunctive Pain Measurement Device For Anesthesiology

Anesthesiology

Rhinoanemometer (Measurement Of Nasal Decongestion)

Anesthesiology

Cabinet, Table And Tray, Anesthesia

Anesthesiology

Spreader, Cuff

Anesthesiology

Stethoscope, Esophageal

Anesthesiology

Oral Airway Assist

Anesthesiology

Spirometer, Diagnostic

Anesthesiology

Device, Positive Pressure Breathing, Intermittent

Anesthesiology

Sparse Sample Pk Profile And Dosing Software

Anesthesiology

Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

Airway, Oropharyngeal, Anesthesiology

Anesthesiology

Airway, Nasopharyngeal

Anesthesiology

Device Indicating An Exhalation Event

Anesthesiology

Spacer, Direct Patient Interface

Anesthesiology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology

Apparatus, Gas-Scavenging

Anesthesiology

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Anesthesiology

Circulator, Breathing-Circuit

Anesthesiology

Percussor, Powered-Electric

Anesthesiology

Laryngoscope, Rigid

Anesthesiology

Blood Specimen Collection Kit (Excludes Hiv Testing)

Anesthesiology

Catheter, Nasal, Oxygen

Anesthesiology

Stimulator, Nerve, Ac-Powered

Anesthesiology

Valve, Switching (Ploss)

Anesthesiology

Stool, Anesthesia

Anesthesiology

Analyzer, Gas, Nitrogen, Gaseous-Phase

Anesthesiology

Stimulator, Nerve, Battery-Powered

Anesthesiology

Mask, Oxygen, Non-Rebreathing

Anesthesiology

Vaporizer, Anesthesia, Non-Heated

Anesthesiology

Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology

Cardiopulmonary Resuscitation Aid Kit

Anesthesiology

Catheters, Suction, Tracheobronchial

Anesthesiology

Spinal Anesthesia Kit

Anesthesiology

Analyzer, Nitrogen Dioxide, Exempt

Anesthesiology

Calibrator, Pressure, Gas

Anesthesiology

Needle, Conduction, Anesthetic (W/Wo Introducer)

Anesthesiology

Protector, Dental

Anesthesiology

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Anesthesiology

Valve, Non-Rebreathing

Anesthesiology

Monitor, Breathing Frequency

Anesthesiology

Hood, Oxygen, Infant

Anesthesiology

Medevac Use Oxygen Generator

Anesthesiology

Support, Patient Position

Anesthesiology

Strap, Head, Gas Mask

Anesthesiology

Tube, Tracheostomy (W/Wo Connector)

Anesthesiology