ICU Medical 14001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709100121), received between Jun 18, 2024 and Jun 21, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

11 other recalls cover devices cleared under the same FDA submission (K141789); 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 21, 2026No Flow

  A REPORTED INCIDENT INVOLVING A PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR INDICATED FAILURE OF FLUID TO PASS FROM AN EXTENSION SET SYSTEM TO THE SET¿S CHAMBER DURING USE. HOWEVER, THE SYSTEM FUNCTIONED CORRECTLY WHEN CONNECTED TO AN ALTERNATE PORT. THERE WAS PATIENT INVOLVEMENT AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572567 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER, 15 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-SITE, POLYETHYLENE LINED LIGHT RESISTANT TUBING, SECURE LOCK, 213 CM WHERE IT WAS REPORTED THAT IT BEGAN TO LEAK WITH THE ADMINISTRATION OF THE PREMEDICATION. ALTHOUGH THE EVENT OCCURRED DURING INFUSION, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303440 ↗
• MalfunctionOct 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER WHERE THE CUSTOMER REPORTED THAT WHEN CONNECTING THE EXTENSION TUBE (WHICH CAME PREPARED FROM THE PHARMACY) TO ONE OF THE ACCESS CLAVES FOR ADMINISTERING CYTOSTATICS, IT WAS NOT POSSIBLE TO PASS THE MEDICINE THROUGH. THE CLAVE WAS OBSTRUCTED INTERNALLY AND DID NOT ALLOW THE MEDICINE TO PASS THROUGH (THE CONNECTIONS ARE CLAVE SPIRALS AND WERE PERFECTLY HOOKED). THE NURSES CHANGED THE ACCESS FROM THE EXTENSION ROD TO ANOTHER KEY ON THE SAME DEVICE AND WERE ABLE TO PASS THE MEDICATION THROUGH WITHOUT ANY PROBLEMS. THE CONCLUSION WAS THAT THE KEYS WERE DAMAGED INTERNALLY AND WOULD NOT ALLOW THE LIQUID TO PASS THROUGH. THE PROBLEM WAS IDENTIFIED WHEN PROGRAMMING THE PUMP, WITH THE DEVICE CONNECTED BY THE CLAVE TO THE SPIRALS AND THE PLUM PUMP EMITTING A DISTAL OCCLUSION BEEP. THIS HAPPENED WITH 3 DEVICES. THE EVENT OCCURRED DURING PATIENT USE, THERE WAS NO ONE HARMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372672 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 MICRON FILTER, POLYETHYLENE LINED TUBING, SECURE LOCK, 225 CM WHERE IT WAS REPORTED THERE WAS LEAKING FROM HOSPIRA FILTER LINE DURING INFUSION. THERE WERE NO CUTS, HOLES OR DEFECTS NOTED ON THE PRODUCT. THE PATIENT WAS UNABLE TO HAVE REMAINING FEW MILLILITERS OF SYSTEMIC ANTI-CANCER TREATMENT (SACT). THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND SPILL WAS CONTAINED. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564109 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141789. One submission often covers many models, so check the product and lot details in each record.

• Z-3162-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• 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-0145-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Mic
• Z-0127-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Line
• Z-0128-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Mic
• Z-3031-2017 · Jun 15, 2017 · Terminated
  Plum 360 Infusion System
• Z-1682-2017 · Dec 30, 2016 · Terminated
  Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
• Z-1832-2016 · Mar 25, 2016 · Terminated
  The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver
• Z-1833-2016 · Mar 25, 2016 · Terminated
  The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With it