Plum 1253905Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10887787005407), received between Jun 27, 2023 and Sep 29, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (40 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

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936116 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923251 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829385 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  The event involved a Primary PLUM Set, 1.2 Micron Filter, CLAVE Y-Site, Secure Lock, 104 Inch reported that the customer had noticed over the past week involving the Primary Plum Set 1.2 Micron Filter Clave Y. Several sets had been found leaking from the filter site during use. They had identified leaks in tubing used for three different patients. The event occurred during use. There was patient involvement and no reported harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818528 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50655407 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652586 ↗
• MalfunctionJun 25, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED WITH A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH. LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT DIFFERENT PLACES ON THE 1.2 MICRON FILTER, ONCE ALONG THE SIDE OF THE FILTER ONCE IN THE BACK WHERE THE LITTLE HOLES OF THE FILTER ARE. PATIENTS ARE USUALLY THE ONES NOTICING THE LEAK WITHIN 10 MINUTES OF STARTING THE INFUSION WITH NEW TUBING. THE CUSTOMER REPORTED THAT THESE LEAKS REQUIRE THE SYSTEM TO BE CHANGED MORE OFTEN THAN NECESSARY, INCREASING THE RISK OF COMPLICATIONS FOR THE PATIENT. THERE WAS A PATIENT INVOLVEMENT; THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25625464 ↗
• MalfunctionJun 25, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED WITH A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH. LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT DIFFERENT PLACES ON THE 1.2 MICRON FILTER, ONCE ALONG THE SIDE OF THE FILTER ONCE IN THE BACK WHERE THE LITTLE HOLES OF THE FILTER ARE. PATIENTS ARE USUALLY THE ONES NOTICING THE LEAK WITHIN 10 MINUTES OF STARTING THE INFUSION WITH NEW TUBING. THE CUSTOMER REPORTED THAT THESE LEAKS REQUIRE THE SYSTEM TO BE CHANGED MORE OFTEN THAN NECESSARY, INCREASING THE RISK OF COMPLICATIONS FOR THE PATIENT. THERE WAS A PATIENT INVOLVEMENT; THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25625407 ↗
• MalfunctionJun 10, 2026Contamination

  AN EVENT INVOLVING A PRIMARY PLUM SET REPORTED THAT BLACK SPECKS WERE FOUND ON THE DRIP CHAMBER WALLS OF INTRAVENOUS (IV) TUBING. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455384 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH IN WHICH IT WAS REPORTED THAT THE LIPID TOTAL PARENTAL NUTRITION (TPN) TUBING WAS LEAKING FROM THE FILTER. THE PROBLEM OCCUR APPROXIMATELY 20 MINUTES THROUGH THE TPN INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149729 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  THE FILTER OF THE FOLLOWING MEDICAL DEVICE: PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH REPORTEDLY WAS SLOWLY EXPELLING DROPS OF TOTAL PARENTERAL NUTRITION (TPN) WHILE A PATIENT'S INFUSION WAS RUNNING. THE ISSUE WAS REPORTED AS NOT BEING CONSISTENT. THERE WERE NO ISSUES FOR ONE TO TWO DAYS; HOWEVER, THE LEAKING LATER OCCURRED MULTIPLE TIMES DURING A ONE SHIFT. THE TPN WAS INFUSED OVER 12 HOURS EACH DAY, STARTING AT 21:00 AND FINISHING AT 09:00. WHEN THE LEAKING OCCURRED, THE PATIENT INFORMED THE NURSE, AND THE TPN TUBING WAS CHANGED. IN SOME INSTANCES, NURSES OBSERVED THE LEAKING WITHIN FIVE MINUTES OF STARTING THE INFUSION. UPON INVESTIGATION AT THE CLINICAL FACILITY, IT SEEMS IT MAY HAVE BEEN HAPPENING ON AND OFF SINCE THE PATIENT'S ADMISSION TO THE UNIT. THERE WERE NIGHTS WHEN THIS OCCURRED FIVE TO SIX TIMES CONSECUTIVELY. ON THE MOST RECENT NIGHT, IT OCCURRED TWICE, AND ON SOME DAYS, THERE WERE NO ISSUES. THE LEAKING OCCURS ON AND OFF DURING ADMINISTRATION OF TPN. ANOTHER PATIENT ON THE SAME UNIT USED TPN TUBING FROM THE SAME LOT NUMBER AND DID NOT REPORT ANY CONCERNS. NO SIMILAR ISSUES HAD BEEN EXPERIENCED PREVIOUSLY. AN INVESTIGATION OF OTHER VARI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045131 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED THE FOLLOWING MEDICAL DEVICE: PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH. LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT DIFFERENT PLACES ON THE 1.2 MICRON FILTER, ONCE ALONG THE SIDE OF THE FILTER ONCE IN THE BACK WHERE THE LITTLE HOLES OF THE FILTER ARE. PATIENTS ARE USUALLY THE ONES NOTICING THE LEAK WITHIN TEN MINUTES OF STARTING THE INFUSION WITH NEW TUBING. THE CUSTOMER REPORTED THAT THESE LEAKS REQUIRE THE SYSTEM TO BE CHANGED MORE OFTEN THAN NECESSARY. THERE WAS NO REPORT OF ANY HUMAN HARM. THIS EMDR REFLECTS NINE OCCURRENCES OF THE SAME FAILURE MODE WITH NO OTHER UNIQUE INFORMATION PROVIDED TO DIFFERENTIATE ANY OF THE EVENTS INDIVIDUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027917 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  CORRECTION: THE EVENT OCCURRED ON AN UNSPECIFIED DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748437 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  THE TUBING OF A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH WAS REPORTEDLY WET DUE TO LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE DURING USE ON A PATIENT. THE PRESSURE ON THE INFUSION PUMP WAS CHECKED (WHILE IT WAS STILL INFUSING) AND IT WAS AT 1.8, THEREFORE, NO HIGH PUMP PRESSURE WAS NOTED. THE LEAK WAS COMING FROM THE CIRCLE ON THE FLAT SIDE OF THE FILTER, AND NOT THE SIDE WHERE THE TUBING CONNECTS. THERE WAS NO HARM TO THE PATIENT THAT WAS INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654234 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE; THE 1ST DAY OF THE MONTH REPORTED HAS BEEN USED AS A PLACEHOLDER. THE EVENT INVOLVED A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH, WHICH WAS REPORTED TO BE LEAKING AT THE WHITE PORT ON THE LIPID TUBING THAT GOES TO THE PUMP AS IT IS VENTED. PATIENT INVOLVEMENT WAS NOT REPORTED; BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606761 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON (B)(6) 2025 AND IT INVOLVED A PRIMARY PLUM SET 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCHES. THE REPORTED STATED THAT THE STAFF NOTICED THE LIQUID WAS LEAKING DURING TUBING CHANGE. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511043 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON (B)(6) 2025 AND IT INVOLVED A PRIMARY PLUM SET 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCHES. THE REPORTED STATED THAT THE STAFF NOTICED THE LIQUID WAS LEAKING DURING TUBING CHANGE. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510868 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON 22-SEP-2025 AND IT INVOLVED A PRIMARY PLUM SET 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH. THE REPORTED STATED THAT THE STAFF NOTICED THE LIQUID WAS LEAKING DURING TUBING CHANGE. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482351 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORTED EVENT OF PERIPHERAL PARENTERAL NUTRITION (PPN) LEAKING AT THE FILTER RESULTING IN PPN HAVING TO BE STOPPED HAD TWO REPORTED OCCURRENCES. THIS REPORT CAPTURES TWO SEPARATE OCCURRENCES INVOLVING THE SAME DEVICE MODEL. NO ADDITIONAL IDENTIFYING INFORMATION WAS AVAILABLE FOR ANY OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416539 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUM SET WHERE IT WAS REPORTED THAT TOTAL PARENTERAL NUTRITION (TPN) LEAKING AT THE FILTER RESULTING IN BAG HAVING TO BE TAKEN DOWN AND THROWN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415670 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 IN REPORTEDLY LEAKED AN UNSPECIFIED FLUID AT THE FILTER A FEW HOURS AFTER ADMINISTRATION ON MULTIPLE DIFFERENT INCIDENTS AND DIFFERENT FLOORS. THERE WAS NO HUMAN HARM. THIS EMDR REFLECTS ONE OF TWO SIMILAR OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405551 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH WHERE THE CUSTOMER REPORTED THAT THERE WAS TOTAL PARENTERAL NUTRITION (TPN) LEAKING FROM THE TUBE. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972193 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH WHERE THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING TPN/LIPIDS AT THE FILTER. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733021 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THAT THERE WERE TWO REPORTS OF POSSIBLE LEAKING FROM THE FILTER WHEN ADMINISTERING TOTAL PARENTERAL NUTRITION (TPN) & LIPIDS CONCURRENTLY. THE NURSE NOTED A STAIN ON THE BED BUT COULDN'T SEE WHERE THE LEAK WAS, BUT THEN THE 2ND TIME THE NURSE SAW FLUID UNDERNEATH THE FILTER AS IT LAID IN THE BED. THEY SAVED THE TUBING AND TRIED TO REPLICATE THE LEAKING. THEY RAN THE PUMP FROM 9AM-4PM. THEY DID SEE ONE SMALL DROP OF FLUID ON THE OUTSIDE OF THE FILTER AFTER THE RATE TITRATED UP TO 133ML/HR. THEY WIPED IT SO THEY COULD SEE WHERE IT CAME FROM, BUT THE FILTER REMAINED DRY. THE LIPIDS THEY HAD RAN OUT SO FOR THE REST OF THE TEST IT WAS JUST THE THINNER IV FLUIDS. THE TUBING USED TO REPLICATE THE ISSUE WAS THE SAME TUBING THAT LEAKED ON THE 2ND INCIDENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE EVENT AND NO DELAY IN THERAPY AS IT WAS FOUND AT THE END OF THE THERAPY, OR TPN & LIPIDS HAD TO BE STOPPED & CHILD PLACED ON ALTERNATIVE THERAPY. THIS CAPTURES 2 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472427 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH WHERE IT WAS REPORTED THAT THERE WERE TWO REPORTS OF POSSIBLE LEAKING FROM THE FILTER WHEN ADMINISTERING TOTAL PARENTERAL NUTRITION (TPN) & LIPIDS CONCURRENTLY. THE NURSE NOTED A STAIN ON THE BED BUT COULDN'T SEE WHERE THE LEAK WAS, BUT THEN THE 2ND TIME THE NURSE SAW FLUID UNDERNEATH THE FILTER AS IT LAID IN THE BED. THEY SAVED THE TUBING AND TRIED TO REPLICATE THE LEAKING. THEY RAN THE PUMP FROM 9AM-4PM. THEY DID SEE ONE SMALL DROP OF FLUID ON THE OUTSIDE OF THE FILTER AFTER THE RATE TITRATED UP TO 133ML/HR. THEY WIPED IT SO THEY COULD SEE WHERE IT CAME FROM, BUT THE FILTER REMAINED DRY. THE LIPIDS THEY HAD RAN OUT SO FOR THE REST OF THE TEST IT WAS JUST THE THINNER IV FLUIDS. THE TUBING USED TO REPLICATE THE ISSUE WAS THE SAME TUBING THAT LEAKED ON THE 2ND INCIDENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE EVENT AND NO DELAY IN THERAPY AS IT WAS FOUND AT THE END OF THE THERAPY, OR TPN & LIPIDS HAD TO BE STOPPED & CHILD PLACED ON ALTERNATIVE THERAPY. THIS CAPTURES 1 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472419 ↗

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