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Plum 1203012Recalls & reported problems

ICU Medical, Inc. · LIFESHIELD, Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 104 Inch · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787005193), received between Jan 22, 2019 and Aug 14, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak2
  • Particulates1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PLUMSET THAT WAS NOTED TO HAVE CHEMO DRUG THAT LEAKED ON THE AIR VENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8894722 ↗
  • MalfunctionMay 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENT INVOLVED A PLUMSET THAT LEAKED 3-4 DROPS OF IFOSFAMIDE WHEN INFUSED OVER 24 HOURS. THE CUSTOMER REPORTED THAT THERE WERE NO OBVIOUS DEFECTS NOTED ON THE TUBING SET; NO HOLE, CUT, TEARS OR ANY OTHER DEFECTS NOTED. THE TUBING WAS NOT REPLACED AND THERAPY WAS NOT RESUMED. THERE WAS NO ADVERSE EVENT REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8588568 ↗
  • MalfunctionJan 22, 2019Particulates; Particulates

    THE EVENT INVOLVED A PLUM SET ON AN UNSPECIFIED DATE THAT WAS REPORTED TO HAVE IMPURITIES INSIDE THE TUBE. THERE WAS NO REPORT OF HUMAN HARM, NOR ADVERSE EVENT, NOR MEDICAL INTERVENTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8267315 ↗

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-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-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-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-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
  • 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

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

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