Plum 360Recalls & reported problems across all models

We found 3 models of Plum 360 by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2017 and Feb 24, 2026 — classified as 3 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Plum 360 problems

Plum 360 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Plum 360 30010

  Pump, infusion
  44 reports
• Plum 360 300100414

  Pump, infusion
  10 reports
• Plum 360 300100413

  Pump, infusion
  1 report

Recent Plum 360 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Air/Gas in Device

  AN EVENT INVOLVING A PLUM 360 REPORTED THAT THE INTRAVENOUS (IV) PUMP WAS ALARMING FOR PROXIMAL AIR WHILE INFUSING NOREPINEPHRINE. BACK PRIMING WAS DONE, AND NO AIR BUBBLES WERE SEEN IN THE SYRINGE. HOWEVER, AFTER RESTARTING THE PUMP, THE ALARM FOR AIR PERSISTED, AND THE PROCESS WAS REPEATED MULTIPLE TIMES WITH NO AIR DETECTED EACH TIME. DUE TO THE INTERRUPTIONS IN THE NOREPINEPHRINE INFUSION, THE PATIENT'S BLOOD PRESSURE DROPPED TO 72/54, THEN 59/51, REQUIRING A REGISTERED NURSE (RN) TO ADMINISTER 200 MCG OF IV PHENYLEPHRINE. THE IV LINE AND PUMP WERE REPLACED, AND A NEW INFUSION WAS STARTED WITH NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24438715 ↗
• MalfunctionMay 9, 2025Unexpected Shutdown; Unexpected Shutdown

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN UNSPECIFIED PLUM 360 INFUSION PUMP. THE DEVICE REPORTEDLY TURNED OFF UNEXPECTEDLY WHILE IN AN ELEVATOR. IT WAS NOT REPORTED WHETHER OR NOT THE PUMP ALARMED BEFORE IT SHUT DOWN. THE CUSTOMER IS CLAIMING AN UNSPECIFIED SENTINEL EVENT WITHOUT ANY FURTHER DETAILS. ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION SURROUNDING ANY PATIENT DETAILS AND THE EVENT, HOWEVER, THERE IS NO ADDITIONAL INFORMATION AVAILABLE TO PROVIDE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994277 ↗
• MalfunctionFeb 5, 2025Unexpected Shutdown; Unexpected Shutdown

  A MEDWATCH WAS RECEIVED REGARDING AN UNSPECIFIED PLUM 360 THAT EXPERIENCED UNEXPECTED SHUTDOWN. IT WAS STATED THAT THE BATTERIES IN THE PUMPS ARE THE CSB BATTERIES. "ONE PUMP HAS FAILED WHILE BEING USED ON PATIENT WITH THE BATTERY ISSUE." THE PUMP HAS BEEN SEQUESTERED. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED. FULL EVENT DESCRIPTION: ICUMEDICAL 360 PLUM IV PUMPS. WE PURCHASE 863 IV PUMPS TWO MONTHS AGO AND SINCE THE GO LIVE DATE WE HAVE HAD 165 HAVE COME TO BIOMED WITH A REPLACED BATTERY ALARM, ICU FSE. ERROR CODE "N56 REPLACE BATTERY" ICU MEDICAL HAS REPLACED 167 BATTERIES BUT TWO OF THE PUMPS CAME BACK WITH THE SAME PROBLEM. A LITTLE OVER 20% OF OUR PUMPS FAILED SINCE FIRST PURCHASE. ICU MEDICAL ASSURED US BEFORE OUR GO LIVE DATE THAT BATTERY ISSUE WAS FIXED. THE FIRST NOTIFICATION OF PUMP BATTERIES BEING DEAD WHILE PLUGGED IN WAS ON (B)(6) 2024 AND WAS IMMEDIATELY ESCALATED TO ICU MEDICAL. THE BATTERIES IN THE PUMPS ARE THE CSB BATTERIES. ONE PUMP HAS FAILED WHILE BEING USED ON PATIENT WITH THE BATTERY ISSUE. THE PUMP HAS BEEN SEQUESTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317504 ↗
• MalfunctionJan 15, 2025Unexpected Shutdown; Unexpected Shutdown

  THE EVENT INVOLVED A PLUM 360 PUMP WHERE THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN WHILE PLUGGED IN AND INFUSING FLUIDS TO A PATIENT. THE BATTERY USED WAS A NEW CSB. THERE WAS PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163528 ↗
• MalfunctionJan 9, 2025Unexpected Shutdown; Unexpected Shutdown

  THE EVENT INVOLVED AN UNSPECIFIED ICU MEDICAL PLUM 360 PUMP WHERE A PATIENT HAD A CARDIZEM DRIP INFUSING, AND THE PUMP TURNED OFF WITHOUT ANY NOTIFICATION. THE PUMP OFF BUT CONTINUED TO ALARM WITH NO ABILITY TO SHUT OFF, NO WARNING SIGN OF THIS OCCURRING. THE PATIENT IS A 44-YEAR-OLD, WHITE, NON-HISPANIC, FEMALE WEIGHING 61KG. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21121024 ↗
• MalfunctionJan 9, 2025Unexpected Shutdown; Unexpected Shutdown

  THE EVENT INVOLVED AN UNSPECIFIED PLUM 360 PUMP WHERE IT WAS NOTED THAT IT FAILED DUE TO THE BATTERY WHILE INFUSING MEDICATION. THE BATTERY WAS A NEW CSB. THERE WAS PATIENT INVOLVEMENT, AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120992 ↗
• MalfunctionJan 2, 2025Unexpected Shutdown; Unexpected Shutdown

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PLUM 360 INFUSION PUMP. THE CUSTOMER REPORTED THAT THE PUMP KEEPS PERFORMING SELF-CHECK AND SHUTTING DOWN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063156 ↗
• MalfunctionDec 6, 2024No Audible Alarm; Unexpected Shutdown; No Audible Alarm; Unexpected Shutdown

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PLUM 360 INFUSION PUMP WHERE IT WAS REPORTED TO CHECK BATTERY STATUS, PUMP DOES NOT GIVE ALARM WHEN FINISHED (IT TURNS OFF). THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS "AFTER UPDATE". THERE IS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT / HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863417 ↗
• MalfunctionDec 6, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PLUM 360 INFUSION PUMP WHERE IT WAS REPORTED REPLACEMENT OF THE COVER + BATTERY, AND THE FLOW RATE IS NON-COMPLIANT. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT IS UNKNOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT/HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863008 ↗
• MalfunctionNov 15, 2024No Audible Alarm; Alarm Not Visible; Air/Gas in Device; No Audible Alarm; Alarm Not Visible; Air/Gas in Device

  THE EVENT INVOLVED A PLUM 360¿ INFUSER WHERE THE REPORTER STATED THAT THEY NOTICED BUBBLES INSIDE THE PLUM CASSETTE AND ALONG THE TUBING LINE (GOING TO PATIENT). THE ALARM DID NOT GO OFF, SO I BACK PRIMED IT TO REMOVE THE BUBBLES, AND I REMOVED THE BUBBLES IN THE TUBING LINE (GOING TO PATIENT) WITH A SYRINGE. NO FLUID BUBBLES WERE INFUSED TO THE PATIENT, NO HARM DONE TO THE PATIENT. PER MANUFACTURER'S PRODUCT INFO: THE AIR TRAP IN THE PLUM CASSETTE CAN CAPTURE UP TO 1 ML OF AIR BEFORE ALARMING, IF AN AIR-IN-LINE ALARM DOES OCCUR, AIR CAN BE EASILY REMOVED WITH AUTOMATED BACK PRIMING WITHOUT DISCONNECTING FROM THE PATIENT. THE ISSUE IS THE ICU MEDICAL PLUM 360 PUMP IS ITS INABILITY TO DETECT THE FLUID BUBBLES IN THE PLUM CASSETTE AND WAS ABLE TO PASS THRU THE PLUM CASSETTE TO THE TUBING LINE GOING TO THE PATIENT; POSING A HAZARD/ RISK TO HAVE THESE FLUID BUBBLES GO TO PATIENT'S BLOOD. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695133 ↗
• MalfunctionSep 30, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND WAS IN REGARD TO A GENERAL COMPLAINT REGARDING AIR BUBBLE ISSUES ON ICU MEDICAL INFUSION PUMPS, SPECIFICALLY PLUM 360. THE CUSTOMER REPORTED THAT THE PUMP HAD AIR IN THE LINE BUT CONTINUED TO INFUSE DURING USE ON A PATIENT. THE CUSTOMER FURTHER STATED THAT IT SEEMS TO ONLY OCCUR WHEN THE NURSES ARE DOING THE IVIG INFUSIONS WHERE MICROBUBBLES APPEAR PAST THE PLUM CASSETTE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE AIR SEEMED TO BE MORE OF A FOAM THAT DEVELOPED WITH A SPECIFIC MEDICATION AND THERE WAS NOT TRULY A LARGE AIR BUBBLE THAT DEVELOPED IN THE LINE. SO, THE PUMP CONTINUED TO INFUSE, BUT THAT IS BECAUSE THE LIQUID APPEARED TO BE MORE OF A FOAM AS IT WAS INFUSED INTO THE PATIENT. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339945 ↗
• MalfunctionAug 27, 2024Unexpected Shutdown; Unexpected Shutdown

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING AN UNKNOWN PLUM DEVICE. AS PER REPORT THE DEVICE POWERED DOWN. THE EVENT OCCURRED DURING PATIENT TRANSPORT. THERE WAS PATIENT INVOLVEMENT, UNKNOWN HARM/ADVERSE EVENT REPORTED AND UNKNOWN DELAY OF THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078057 ↗
• MalfunctionAug 20, 2024Unexpected Shutdown; Unexpected Shutdown

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE (SOMETIME DURING WEEK OF (B)(6), 2024) AND INVOLVED AN UNIDENTIFIED PLUM 360 15.2 LARGE VOLUME INFUSION PUMP. THE CUSTOMER STATED THAT NURSING REPORTED THAT THE PUMPS WERE POWERING OFF IN THE MIDDLE OF AN INFUSION (WHILE PATIENT WAS RECEIVED IV FLUIDS) TO ACCEPT DRUG LIBRARY UPDATES. THE CUSTOMER STATED THAT THEY HAD THE PUMPS SINCE 2021 AND THIS IS THE FIRST THEY HAVE BEEN INFORMED OF THIS. THE CUSTOMER STATED THAT THE PUMPS SHOULD ACCEPT IT WITHOUT COMPLETELY POWERING DOWN. THERE WAS PATIENT INVOLVEMENT, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION, NO DELAY IN THERAPY; THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003512 ↗
• 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 ↗
• MalfunctionJul 27, 2022Protective Measures Problem

  WHILE INFUSING IV PUMP ALARMED STATING INFUSION DOOR OPENED, PLEASE CLOSE. WHEN DOOR WAS OPENED AND CLOSED AGAIN PUMP THEN WAS FROZEN.

  Patient problems: Insufficient Information

  MAUDE report 15111681 ↗

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