Plum 360 300100414Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M3353001004141), received between Aug 20, 2024 and May 9, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗

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