Plum 1424828Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10887787006183), received between Jan 13, 2020 and Sep 24, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Free or Unrestricted Flow

  The event involved a Primary PLUMSET, PE Lined Tubing, 107 Inch. It was reported that even after pressing the stop button, the medicine keeps flowing and won't stop. This issue led to over delivery during infusion. There was patient involvement but no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883060 ↗
• MalfunctionSep 17, 2026Free or Unrestricted Flow

  A reported incident involving a Primary PLUMSET, PE Lined Tubing, 107. It was reported that the drip could not be locked and continued to flow. There was patient involvement; however, no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805951 ↗
• MalfunctionJun 21, 2026Fluid/Blood Leak

  AN EVENT INVOLVING THE PRODUCT PRIMARY PLUMSET, PE LINED TUBING, 107 INCH REPORTING AFTER CONNECTING THE IV DRIP, WATER DROPLETS SLOWLY SEEPED OUT FROM THE AIR VENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572389 ↗
• MalfunctionJan 22, 2026No Flow

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE THE CUSTOMER REPORTED THAT THE SET HAD AN OCCLUSION AND BLOOD IN THE PRIMARY LINE. THE EVENT WAS NOTED DURING INFUSION OF 5FU. THERE WERE NO OBVIOUS DEFECTS NOTED ON THE PRODUCT AND NO OTHER DEFECTS NOTED. THE PRODUCTS WERE STORED IN AN AIR-CONDITIONED ROOM. THERE WAS PATIENT INVOLVEMENT, A REPORTED DELAY IN THERAPY BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147088 ↗
• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED INVOLVING A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE THEY REPORTED THAT ETOPOSIDE LEAKAGE FROM AIR VANT DURING INFUSION. THERE WAS NO REPORTED DRUG INVOLVED, AND NO BLEED BACK. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM/ADVERSE AND NO DELAY IN CRITICAL THERAPY AS A RESULT OF THIS EVENT. ONLY ONE (1) SAMPLE WAS REPORTED TO BE AFFECTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716680 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE IT WAS STATED IN THE REPORT THAT THERE WAS A LEAKAGE AT DRIP CHAMBER AND CASSETTE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542586 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH THAT EXPERIENCED LEAKAGE. IT WAS STATED IN THE REPORT THAT THERE WAS A LEAKAGE EVEN WHEN THE VENT COVER IS PROPERLY SEALED. THERE IS TWO QUANTITIES AFFECTED AND SAMPLES ARE RETURNING FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. EVENT WAS NOTED DURING INFUSION. AND THE SET WAS CONNECTED TO AN EXTENDED FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22454294 ↗
• MalfunctionApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE A LEAKAGE OF A CHEMO DRUG INSIDE THE TUBE LINE THAT REACHED ON THE IV PUMP WAS REPORTED. THE EVENT OCCURRED DURING INFUSION, THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THERE WERE 2 MATING DEVICES CONNECTED TO THE COMPLAINT PRODUCTS. THE LIST NUMBERS FOR MATING DEVICES ARE CH3034, 011-C32029. NO COMPLAINTS REPORTED ON THESE MATING DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748816 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH THAT EXPERIENCED LEAKAGE. IT WAS STATED IN THE REPORT THAT THERE WAS A WATER LEAKAGE FROM THE CAP ABOVE THE DRIP CHAMBER. PATIENT INVOLVEMENT AND PATIENT HARM/ADVERSE EVENT ARE UNKNOWN. SAMPLE PICTURE IS AVAILABLE. THERE IS ONE QUANTITY AFFECTED AND ONE SAMPLE IS RETURNING FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733949 ↗
• MalfunctionJan 8, 2025Crack; Crack

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE A CRACK ON LUER LOCK WAS REPORTED. A PICTURE OF A SET WHERE FLUIDS WERE NOTED INSIDE THE TUBING AND A PICTURE WHERE THE LUER LOCK CRACKED WERE PROVIDED. THE PACKAGING WAS SEALED OR INTACT PRIOR TO OPENING. UNKNOWN AS TO HOW THE EVENT WAS NOTED. THE SET WAS REPLACED, AND THERAPY RESUMED WITHOUT ANY PROBLEM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102738 ↗
• MalfunctionApr 19, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WITH LIST NUMBER WHERE IT WAS REPORTED THAT THE DEVICE HAD A CRACK, AND THE VENTS WERE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. THIS CAPTURES 3 OF 4 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143675 ↗
• MalfunctionApr 19, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WITH LIST NUMBER WHERE IT WAS REPORTED THAT THE DEVICE HAD A CRACK, AND THE VENTS WERE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. THIS CAPTURES 4 OF 4 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143673 ↗
• MalfunctionApr 19, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WITH LIST NUMBER WHERE IT WAS REPORTED THAT THE DEVICE HAD A CRACK, AND THE VENTS WERE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. THIS CAPTURES 2 OF 4 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143661 ↗
• MalfunctionApr 19, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WITH LIST NUMBER WHERE IT WAS REPORTED THAT THE DEVICE HAD A CRACK, AND THE VENTS WERE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. THIS CAPTURES 1 OF 4 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143654 ↗
• MalfunctionApr 2, 2024Leak/Splash; Leak/Splash

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE IT WAS REPORTED THAT LEAKING WAS NOTED BETWEEN TUBE AND CASSETTE DURING INFUSION (THERE WAS FLUID NOTED ON THE GROUND). SET WAS USED AT 15:15 AND LEAKAGE WAS NOTED AT 16:45. THE SET WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19029765 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE IT WAS REPORTED LEAKAGE ON SECURE LOCK ADAPTER DURING PATIENT USE. THE SET WAS REPLACED, AND THERAPY RESUMED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899935 ↗
• MalfunctionFeb 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE THE CUSTOMER REPORTED A CHEMO DRUG LEAKED FROM FILTER VENT DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773397 ↗
• MalfunctionFeb 21, 2024No Flow; No Flow

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE THERE CUSTOMER REPORTED THE PATIENT THERAPY NITROGLYCERIN (NTG) WAS INTERRUPTED DUE TO A N185 ALARM ON PLUM A+ INFUSION PUMP. NO OBVIOUS DEFECTS WERE NOTED ON THE TUBING SET LIKE CRACKS OR BREAKS AND NO HOLE, CUT, TEARS OR ANY OTHER DEFECTS NOTED. THE TUBING WAS REPLACED AND THERAPY RESUMED. THE PRODUCTS WERE STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL AND WERE NOT EXPOSED IN EXTREME TEMPERATURE CONDITION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS REPORT TWO OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753428 ↗
• MalfunctionFeb 21, 2024No Flow; No Flow

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE THERE CUSTOMER REPORTED THE PATIENT THERAPY NITROGLYCERIN (NTG) WAS INTERRUPTED DUE TO A N185 ALARM ON PLUM A+ INFUSION PUMP. NO OBVIOUS DEFECTS WERE NOTED ON THE TUBING SET LIKE CRACKS OR BREAKS AND NO HOLE, CUT, TEARS OR ANY OTHER DEFECTS NOTED. THE TUBING WAS REPLACED AND THERAPY RESUMED. THE PRODUCTS WERE STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL AND WERE NOT EXPOSED IN EXTREME TEMPERATURE CONDITION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS REPORT ONE OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753168 ↗
• MalfunctionJan 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE IT WAS REPORTED THAT DURING INSULIN INFUSION. THE REGISTERED NURSE (RN) WENT TO INITIATE NEW INFUSION, THEN IDENTIFIED DIFFERENT INFUSION BACK FILLING WITH BLOOD FROM FEMORAL CENTRAL VENOUS CATHETER (CVC) CATHETER LINE INTO INFUSION TUBING AND BLOOD LEAKING OUT ONTO BED. IDENTIFIED A SMALL CRACK IN LINE. UNKNOWN HOW LONG LINE WAS OPEN, CASE FOLLOWED BY INFECTION CONTROL FOR RISK OF CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484979 ↗
• MalfunctionJan 5, 2024Partial Blockage; No Flow; Partial Blockage; No Flow

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH THAT REPORTEDLY GENERATED AN N185 (CASSETTE TEST FAILURE) ALARM WHEN ATTEMPTED ON EACH OF FIVE INFUSION PUMPS DURING INFUSION. THERE WERE NO ISSUES WITH THE 5 PUMPS, AS THE PUMPS WORKED FINE WITH OTHER SETS. THE SOLUTION/MEDICINE INVOLVED WAS AMIODARONE/NTG. THERE WERE NO OBVIOUS DEFECTS NOTED ON THE TUBING SET (NO CRACKS OR BREAKS, HOLES, CUTS, TEARS OR ANY OTHER DEFECTS). THE TUBING SET WAS REPLACED, AND THERAPY RESUMED. THE PRODUCTS WERE STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL AND WERE NOT EXPOSED TO EXTREME TEMPERATURE. THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451628 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE IT WAS REPORTED THERE WAS LEAKAGE ON TUBING. THE EVENT WAS NOTED DURING INFUSION OF AN UNKNOWN SOLUTION. THERE WAS NO UNPROTECTED DRUG EXPOSURE TO PATIENT OR HEALTHCARE PROVIDER. THERE WAS NO OTHER PHYSICAL DEFECT NOTED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO HEALTHCARE PROVIDER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317501 ↗
• MalfunctionNov 7, 2023Material Separation; Material Separation

  THE INCIDENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE TUBING CONNECTION CAME APART. THE TUBING WAS INFUSING WITH SALINE CONNECTED TO DILUADID PATIENT CONTROLLED ANALGESIA (PCA). THE TUBING SEPARATION/DISCONNECTION OCCURRED AT LEAST AN HOUR INTO INFUSION. THERE WAS NO BLOOD LOSS OR BLEED BACK. ALL TUBING WAS REPLACED. THE SET-UP WAS WITH PE LINED TUBING Y CONNECTED TO PCA TUBING INTO A PERIPHERAL IV. THERE WAS PATIENT INVOLVED BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085121 ↗
• MalfunctionOct 19, 2023No Flow; No Flow

  THE EVENT INVOLVED A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH WHERE IT WAS REPORTED THE INFUSION BY GRAVITY WAS NORMAL, BUT WHEN INFUSING BY PUMP, THE PUMP SHOWED OCCLUSION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965609 ↗
• MalfunctionSep 30, 2023No Flow; No Flow

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A PRIMARY PLUMSET, PE LINED TUBING, 107 INCH GENERATED AN ALARM, FOR THE PUMP IN USE, AT THE TIME OF THE EVENT. HEALTHCARE PROVIDERS REPLACED THE PUMP, BUT THE ISSUE REMAINED. THEY REPLACED THE SET AND THERAPY RESUMED. THERE WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849285 ↗

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-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