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Plum 1194802Recalls & reported problems

ICU Medical, Inc. · LIFESHIELD, Primary PLUM MICRODRIP 150 mL Burette Set, CLAVE Injection Site, 2 CLAVE Y-Sites, Secure Lock, 124 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 10887787005179), received between Apr 19, 2018 and Jun 4, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Chemical Spillage” (1 report).

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

  • Chemical Spillage1
  • Device Contamination with Chemical or Other Material1
  • Device Slipped1
  • Particulates1

Patient problems

  • No Consequences Or Impact To Patient3

Recent adverse event reports

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

  • MalfunctionJun 4, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    THE EVENT INVOLVES A PLUM SET THAT THE INFUSION SET NEEDLE HAS A YELLOW FOREIGN BODY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10118936 ↗
  • MalfunctionMay 14, 2019Particulates; Particulates

    IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, THE TUBING INVOLVED IN THE EVENT WAS NOTICED TO HAVE UNKNOWN IMPURITIES IN THE FLUID PATH OF THE PATIENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8609640 ↗
  • MalfunctionApr 19, 2018Device Slipped; Chemical Spillage

    THE CLEAR FLEXIBLE TUBING THAT GOES INTO THE SPIKE SLID OUT OF THE SPIKE CAUSING TPN TO SPILL. WHEN I PLACE THE FLEXIBLE TUBING BACK INTO THE BOTTOM OF THE SPIKE, IT PULLS OUT VERY EASILY. THE DEVICE WAS RETAINED HOWEVER PACKING AS DISPOSED OF. THIS DID NOT NEGATIVELY IMPACT THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7442745 ↗

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-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-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-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

Other Set, administration, intravascular devices

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Sources and updates

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