Plum 1468728Recalls & reported problems

Summary

The FDA's MAUDE database contains 482 adverse event reports that list this exact device (DI 10887787005650), received between May 10, 2019 and Sep 25, 2026 — classified as 2 deaths, 6 injuries, 474 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (213 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 12, 2026Open, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3156-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 482 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903120 ↗
• MalfunctionSep 25, 2026Environmental Particulates

  The event involved a Primary Plum Set reported that there is dirt in the drip chamber. The issue was noted during priming. There were no concomitant drug and concomitant device involved. There was no bleedback, no biohazard, no user facility MedWatch, and no chemo. The device was not reprocessed or resterilized.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897908 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873863 ↗
• MalfunctionSep 23, 2026Break; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873245 ↗
• MalfunctionSep 23, 2026Crack; Fluid/Blood Leak

  The event involved a Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch reported that when RN was back priming secondary and noted leaking at the cassette. RN stopped back priming and clamped secondary line due to dripping. Upon further inspection, it was found that there was a crack in the connector from the secondary to the cassette under the blue piece. The RN opened the chamber of the pump, and the connector broke off from the cassette, staying attached to the secondary line. The event occurred during priming.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871967 ↗
• MalfunctionSep 22, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860468 ↗
• MalfunctionSep 17, 2026Break; Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50806245 ↗
• MalfunctionSep 11, 2026Particulates

  The event involved Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch. It was reported that there seemed to be a hair or eyelash floating in the solution, which was supposed to be sterile. It occurred Upon drawing up saline into the drip chamber, the floating feather like thing floated within the chamber (not present within the saline). There was patient involvement (but the nurse saw the feather and reported the fault before the patient was affected) and no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50729546 ↗
• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177568 ↗
• MalfunctionAug 5, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147389 ↗
• MalfunctionJun 22, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHICH WAS REPORTED THAT THEY HAD MULTIPLE CONTAMINATED PRIMARY PLUM SETS - ONE SET HAD BEEN SPIKED TO A ZOSYN BAG BUT WAS CAUGHT PRIOR TO PATIENT USE. SOME ARE SMALL TO LARGE BROWN SPOTS. IN TOTAL, 66 WERE IDENTIFIED AS CONTAMINATED. THERE WAS VISIBLE CONTAMINATION IN THE DRIP CHAMBER. AS A RESULT, THEY SET ASIDE ALL OF THEIR SETS WITH THE SAME LOT NUMBER. SAMPLE PHOTOS WERE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585643 ↗
• MalfunctionJun 20, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHICH WAS REPORTED THAT THEY FOUND BLACK SPOT IN THE DRIP CHAMBER WITH POTENTIAL CONTAMINATE. IT WAS REPORTED THAT THE PRODUCT WAS OUT IN PATIENT CARE AREAS FOR PATIENT USE BUT HAD NOT BEEN USED YET. PACKAGE WAS SEALED WHEN FOUND. ONCE FOUND OPENED PACKAGE TO CLOSER LOOK AT IF IT APPEARED THE SPOT WAS ON THE OUTSIDE OF THE DRIP CHAMBER OR THE INSIDE AND IT APPEARED TO LOOK LIKE ON THE INSIDE OF THE DRIP CHAMBER. THE MEDWATCH FORM MW5188388 WAS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25570257 ↗
• MalfunctionJun 20, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH THAT THE MEDICAL CENTER DISCOVERED VISIBLE CONTAMINATION OF IV TUBING CONTAINING A SMALL BLACK DOT ON THE INTERNAL DRIP CHAMBER OF AN IV TUBING SET FROM ICU MEDICAL. THIS TUBING WAS NOT IN PATIENT USE AND SUPPLY INVENTORY WAS BEING INSPECTED AFTER RECEIVING A CORRESPONDENCE BULLETIN ABOUT THE ISSUE FROM DEPARTMENT OF HEALTH AND HUMAN SERVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25570028 ↗
• MalfunctionJun 19, 2026Contamination

  AN EVENT INVOLVING AN UNSPECIFIED DATE WITH PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK (103-INCH) WAS REPORTED, IN WHICH THE CUSTOMER IDENTIFIED TUBING WITH A BLACK SPECK VISIBLE IN THE DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566694 ↗
• MalfunctionJun 19, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561998 ↗
• MalfunctionJun 18, 2026Particulates

  THE MEDWATCH MW5188303 WAS RECEIVED ON BEHALF OF A CUSTOMER FACILITY. THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCHES. IT WAS REPORTED THAT THE DEVICE DID NOT REACH A PATIENT. A DARK BROWN SPOT WAS NOTED ON THE INTERNAL CHAMBER. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553445 ↗
• MalfunctionJun 18, 2026Particulates

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WITH LIST NUMBER 14687-15 AND LOT UNKNOWN. IT WAS STATED IN THE REPORT THAT THERE IS DIRT INSIDE THE DRIP CHAMBER. EVENT WAS NOTED UPON OPENING THE PACKAGE. NO DRUG WAS INVOLVED IN THE EVENT. THERE WAS NO BLEEDBACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD AND THE DEVICE WAS NOT REPROCESSED /RESTERILIZED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552443 ↗
• MalfunctionJun 17, 2026Contamination

  AN EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THAT THE PRODUCT APPEARED TO HAVE HAIR OR FIBER PARTICLE INSIDE THE CHAMBER. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532455 ↗
• MalfunctionJun 17, 2026Contamination

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH, AND IT WAS REPORTED THAT THE PRODUCT APPEARED TO HAVE HAIR OR FIBER PARTICLE INSIDE THE CHAMBER BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530949 ↗
• MalfunctionJun 17, 2026Contamination

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCHES, AND IT WAS REPORTED THAT THE PRODUCT APPEARED TO HAVE HAIR OR FIBER PARTICLE INSIDE THE CHAMBER BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530935 ↗
• MalfunctionJun 17, 2026Contamination

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH, AND IT WAS REPORTED THAT THE PRODUCT APPEARED TO HAVE HAIR OR FIBER PARTICLE INSIDE THE CHAMBER. THE ISSUE IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530922 ↗
• MalfunctionJun 17, 2026Contamination

  THE EVENT INVOLVED A PRIMARY SET, AND IT WAS REPORTED THAT BLACK DOTS NOTED IN IV TUBING. THERE WERE UNKNOWN PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530534 ↗
• MalfunctionJun 16, 2026Contamination

  AN EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THAT DURING SET UP A BLACK SPECK WAS FOUND IN THE DRIP CHAMBER AFTER THE IV FLUID BAG HAD BEEN SPIKED AND BEFORE IT HAD BEEN CONNECTED TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519244 ↗
• MalfunctionJun 16, 2026Contamination

  AN EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THAT THERE WAS A BLACK SPECK LOCATED IN/ON THE DRIP CHAMBER OF IV (INTRA- VENOUS) TUBING UPON REMOVAL FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED. SEVEN UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OUT OF WHICH SIX WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THIS REPORT CAPTURES THE FIFTH OF 6 AFFECTED SAMPLES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518954 ↗
• MalfunctionJun 16, 2026Contamination

  AN EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THAT THERE WAS A BLACK SPECK LOCATED IN/ON THE DRIP CHAMBER OF IV (INTRA- VENOUS) TUBING UPON REMOVAL FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED. SEVEN UNUSED PRIMARY PLUM SETS WERE RETURNED FOR INVESTIGATION, OUT OF WHICH SIX WERE FOUND TO HAVE BLACK SPECKS PRESENT IN THE DRIP CHAMBER. THIS REPORT CAPTURES THE SECOND OF 6 AFFECTED SAMPLES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518933 ↗

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-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