Plum 1425528Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10887787005971), received between Dec 17, 2018 and Sep 30, 2026 — classified as 164 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (160 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951774 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951595 ↗
• MalfunctionSep 3, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50581885 ↗
• MalfunctionAug 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378912 ↗
• MalfunctionAug 5, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148389 ↗
• MalfunctionAug 5, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148161 ↗
• MalfunctionJun 19, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUM SET, 0.2-MICRON FILTER, CLAVE Y-SITE, POLYETHYLENE-LINED TUBING, SECURE LOCK, AND 104-INCH TUBING. IT WAS REPORTED THAT THREE TAXOL INFUSION SETS LEAKED DURING ADMINISTRATION. A FEW DROPS OF FLUID WERE OBSERVED ON THE TAXOL FILTER SQUARE PORTION. NO PATIENTS HAD DIRECT EXPOSURE TO THE FLUID DROPS. THE ISSUE WAS DISCOVERED HALFWAY THROUGH THE INFUSION, SO THE SET WAS EXCHANGED AND THE REMAINING INFUSION WAS ADMINISTERED. THE TAXOL SET EXCHANGE CAUSED A 15-MINUTE DELAY IN THERAPY. THIS RESULTED IN A MINOR INCONVENIENCE; HOWEVER, THE DRUG ZYNYZ WAS LOST IN THE LINE THAT WAS EXCHANGED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM OCCURRED.

  Patient problems: Discomfort

  MAUDE report 25564150 ↗
• MalfunctionJun 19, 2026Fluid/Blood Leak

  AN EVENT INVOLVED PRIMARY PLUM SET, 0.2-MICRON FILTER, CLAVE Y SITE, POLYETHYLENE LINED TUBING, SECURE LOCK, 104 INCH IT WAS REPORTED THAT THREE TAXOL INFUSION SETS LEAKED DURING ADMINISTRATION. THE AFFECTED SETS WERE QUARANTINED. PER RN STAFF, A FEW DROPS OF FLUID WERE OBSERVED ON THE ON THE TAXOL FILTER SQUARE PORTION. NO PATIENTS HAVE HAD DIRECT EXPOSURES TO THE FLUID DROPS, BUT THERE WAS A POTENTIAL. THIS WAS DISCOVERED HALFWAY THROUGH SO SET WAS EXCHANGED AND REMAINING INFUSION ADMINISTERED. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562914 ↗
• MalfunctionJun 18, 2026Fluid/Blood Leak

  AN EVENT INVOLVED PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH. DROPS WERE NOTICED ON THE CHAIR AND THE FLOOR SHORTLY AFTER CHEMOTHERAPY WAS STARTED. THE FILTER WAS EXAMINED DUE TO PREVIOUS LEAKS, AND A STREAM WAS NOTICED COMING FROM ONE OF THE HOLES IN THE FILTER. THIS WAS THE SAME SPOT WHERE PREVIOUS LOTS HAD LEAKED. THE INFUSION WAS STOPPED, AND THE PRIMARY LINE WAS CHANGED TO CONTINUE THE REMAINDER OF THE CHEMOTHERAPY. THE CHEMOTHERAPY IN THE LEAKING TUBING WAS LOST, AND THE PATIENT WAS UNABLE TO RECEIVE THE ENTIRE DOSE. THE CHEMOTHERAPY DID NOT COME INTO CONTACT WITH THE PATIENT; IT DRIPPED ONTO THE CHAIR THE PATIENT WAS SITTING ON AND ONTO THE FLOOR. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552041 ↗
• MalfunctionJun 15, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH THAT THERE WERE 4 INCIDENTS OF PE LINED TUBING USED FOR TAXOL LEAKING FROM THE BACK OF THE FILTER AT THE BOISE CIC. THE LEAKS WERE SMALL BUT VISIBLE, WITH DROPS ON THE FLOOR AND NOTICED THE DRIPS ON THE FILTER WITHIN MINUTES AFTER THE INFUSION HAD STARTED. THE RN STOPPED THE INFUSION, CHANGED THE TUBING, AND MONITORED THE TUBING TO WATCH FOR A LEAK. SMALL DRIPS WERE OBSERVED WITH THE SECOND SET OF TUBING ON THE FILTER, AND THE RN STOPPED THE INFUSION AND AGAIN CHANGED THE TUBING. THE INFUSION WAS STARTED A THIRD TIME, WITH A NEW PACKAGE OF TUBING. THE RN OBSERVED FOR LEAKING AND SAW NONE. THE PATIENT RECEIVED THE CHEMOTHERAPY. THERE WAS POTENTIAL PATIENT EXPOSURE TO CHEMOTHERAPY. A SPILL KIT WAS USED TO CLEAN CHEMO THAT LEAKED FROM THE FILTER. THERE WAS NOT A CRITICAL DELAY, AND NO MEDICAL INTERVENTION WAS NEEDED AS THE LEAK WAS VISUALIZED PRIOR TO PATIENT CONTACT. THE MEDICATION INVOLVED WAS 170 MG AT 6 MG PER ML OF PACLITAXEL THAT WAS BEING ADMINISTERED. THE EVENT OCCURRED DURING INFUSION. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503253 ↗
• MalfunctionJun 15, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH THAT THERE WERE 4 INCIDENTS OF PE LINED TUBING USED FOR TAXOL LEAKING FROM THE BACK OF THE FILTER AT THE BOISE CIC. THE LEAKS WERE SMALL BUT VISIBLE, WITH DROPS ON THE FLOOR AND NOTICED THE DRIPS ON THE FILTER WITHIN MINUTES AFTER THE INFUSION HAD STARTED. THE RN STOPPED THE INFUSION, CHANGED THE TUBING, AND MONITORED THE TUBING TO WATCH FOR A LEAK. SMALL DRIPS WERE OBSERVED WITH THE SECOND SET OF TUBING ON THE FILTER, AND THE RN STOPPED THE INFUSION AND AGAIN CHANGED THE TUBING. THE INFUSION WAS STARTED A THIRD TIME, WITH A NEW PACKAGE OF TUBING. THE RN OBSERVED FOR LEAKING AND SAW NONE. THE PATIENT RECEIVED THE CHEMOTHERAPY. THERE WAS POTENTIAL PATIENT EXPOSURE TO CHEMOTHERAPY. A SPILL KIT WAS USED TO CLEAN CHEMO THAT LEAKED FROM THE FILTER. THERE WAS NOT A CRITICAL DELAY, AND NO MEDICAL INTERVENTION WAS NEEDED AS THE LEAK WAS VISUALIZED PRIOR TO PATIENT CONTACT. THE MEDICATION INVOLVED WAS 170 MG AT 6 MG PER ML OF PACLITAXEL THAT WAS BEING ADMINISTERED. THE EVENT OCCURRED DURING INFUSION. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503238 ↗
• MalfunctionJun 15, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH THAT THERE WERE 4 INCIDENTS OF PE LINED TUBING USED FOR TAXOL LEAKING FROM THE BACK OF THE FILTER AT THE BOISE CIC. THE LEAKS WERE SMALL BUT VISIBLE, WITH DROPS ON THE FLOOR AND NOTICED THE DRIPS ON THE FILTER WITHIN MINUTES AFTER THE INFUSION HAD STARTED. THE RN STOPPED THE INFUSION, CHANGED THE TUBING, AND MONITORED THE TUBING TO WATCH FOR A LEAK. SMALL DRIPS WERE OBSERVED WITH THE SECOND SET OF TUBING ON THE FILTER, AND THE RN STOPPED THE INFUSION AND AGAIN CHANGED THE TUBING. THE INFUSION WAS STARTED A THIRD TIME, WITH A NEW PACKAGE OF TUBING. THE RN OBSERVED FOR LEAKING AND SAW NONE. THE PATIENT RECEIVED THE CHEMOTHERAPY. THERE WAS POTENTIAL PATIENT EXPOSURE TO CHEMOTHERAPY. A SPILL KIT WAS USED TO CLEAN CHEMO THAT LEAKED FROM THE FILTER. THERE WAS NOT A CRITICAL DELAY, AND NO MEDICAL INTERVENTION WAS NEEDED AS THE LEAK WAS VISUALIZED PRIOR TO PATIENT CONTACT. THE MEDICATION INVOLVED WAS 170 MG AT 6 MG PER ML OF PACLITAXEL THAT WAS BEING ADMINISTERED. THE EVENT OCCURRED DURING INFUSION. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503206 ↗
• MalfunctionJun 15, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH THAT THERE WERE 4 INCIDENTS OF PE LINED TUBING USED FOR TAXOL LEAKING FROM THE BACK OF THE FILTER AT THE BOISE CIC. THE LEAKS WERE SMALL BUT VISIBLE, WITH DROPS ON THE FLOOR AND NOTICED THE DRIPS ON THE FILTER WITHIN MINUTES AFTER THE INFUSION HAD STARTED. THE RN STOPPED THE INFUSION, CHANGED THE TUBING, AND MONITORED THE TUBING TO WATCH FOR A LEAK. SMALL DRIPS WERE OBSERVED WITH THE SECOND SET OF TUBING ON THE FILTER, AND THE RN STOPPED THE INFUSION AND AGAIN CHANGED THE TUBING. THE INFUSION WAS STARTED A THIRD TIME, WITH A NEW PACKAGE OF TUBING. THE RN OBSERVED FOR LEAKING AND SAW NONE. THE PATIENT RECEIVED THE CHEMOTHERAPY. THERE WAS POTENTIAL PATIENT EXPOSURE TO CHEMOTHERAPY. A SPILL KIT WAS USED TO CLEAN CHEMO THAT LEAKED FROM THE FILTER. THERE WAS NOT A CRITICAL DELAY, AND NO MEDICAL INTERVENTION WAS NEEDED AS THE LEAK WAS VISUALIZED PRIOR TO PATIENT CONTACT. THE MEDICATION INVOLVED WAS 170 MG AT 6 MG PER ML OF PACLITAXEL THAT WAS BEING ADMINISTERED. THE EVENT OCCURRED DURING INFUSION. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503187 ↗
• MalfunctionJun 10, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH, AND IT WAS REPORTED THAT THE DEVICE FOUND WITH BLACK SPECKS IN THE DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455182 ↗
• MalfunctionMay 27, 2026Fluid/Blood Leak

  ON AN UNSPECIFIED DATE, A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH REPORTEDLY LEAKED AT THE FILTER. DURING THE EVALUATION OF THE NEWBORN BABY AND ITS ENVIRONMENT AT THE BEGINNING OF THE SHIFT, THE NURSE NOTICED THAT THE SHEET WAS SOILED AND WET. SHE THEN OBSERVED THE LEAK AT THE FILTER. THEN, THE STAFF CHECKED ALL THE BABIES RECEIVING TOTAL PARENTERAL NUTRITION (TPN), SINCE THIS FILTER IS MANDATORY, AND OBSERVED THE SAME PROBLEM ON THREE OTHER CIRCUITS; 4 AFFECTED TUBING DEVICES. THE BABIES WERE RECEIVING NUTRITION (TPN), WHICH WAS PREPARED ONCE EVERY 24 HOURS BY THE PHARMACY. AS A RESULT, THESE BABIES DID NOT RECEIVE THEIR OPTIMAL NUTRITION FOR A FEW HOURS. ONCE THERE WAS A LEAK IN THE TUBING, THEY REPLACED THE SOLUTION IN ORDER TO AVOID ANY RISK OF INFECTION. THERE WAS NO REPORT OF ANY HARM. THIS EMDR REFLECTS THE THIRD OF 3 EVENTS/OCCURRENCES SPANNING TWO DEFECTIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301466 ↗
• MalfunctionMay 27, 2026Fluid/Blood Leak

  ON AN UNSPECIFIED DATE, A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH REPORTEDLY LEAKED AT THE FILTER. DURING THE EVALUATION OF THE NEWBORN BABY AND ITS ENVIRONMENT AT THE BEGINNING OF THE SHIFT, THE NURSE NOTICED THAT THE SHEET WAS SOILED AND WET. SHE THEN OBSERVED THE LEAK AT THE FILTER. THEN, THE STAFF CHECKED ALL THE BABIES RECEIVING TOTAL PARENTERAL NUTRITION (TPN), SINCE THIS FILTER IS MANDATORY, AND OBSERVED THE SAME PROBLEM ON THREE OTHER CIRCUITS; 4 AFFECTED TUBING DEVICES. THE BABIES WERE RECEIVING NUTRITION (TPN), WHICH WAS PREPARED ONCE EVERY 24 HOURS BY THE PHARMACY. AS A RESULT, THESE BABIES DID NOT RECEIVE THEIR OPTIMAL NUTRITION FOR A FEW HOURS. ONCE THERE WAS A LEAK IN THE TUBING, THEY REPLACED THE SOLUTION IN ORDER TO AVOID ANY RISK OF INFECTION. THERE WAS NO REPORT OF ANY HARM. THIS EMDR REFLECTS THE SECOND OF 3 EVENTS/OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300707 ↗
• MalfunctionMay 27, 2026Fluid/Blood Leak

  ON AN UNSPECIFIED DATE, A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH REPORTEDLY LEAKED AT THE FILTER. DURING THE EVALUATION OF THE NEWBORN BABY AND ITS ENVIRONMENT AT THE BEGINNING OF THE SHIFT, THE NURSE NOTICED THAT THE SHEET WAS SOILED AND WET. SHE THEN OBSERVED THE LEAK AT THE FILTER. THEN, THE STAFF CHECKED ALL THE BABIES RECEIVING TOTAL PARENTERAL NUTRITION (TPN), SINCE THIS FILTER IS MANDATORY, AND OBSERVED THE SAME PROBLEM ON THREE OTHER CIRCUITS; 4 AFFECTED TUBING DEVICES. THE BABIES WERE RECEIVING NUTRITION (TPN), WHICH WAS PREPARED ONCE EVERY 24 HOURS BY THE PHARMACY. AS A RESULT, THESE BABIES DID NOT RECEIVE THEIR OPTIMAL NUTRITION FOR A FEW HOURS. ONCE THERE WAS A LEAK IN THE TUBING, THEY REPLACED THE SOLUTION IN ORDER TO AVOID ANY RISK OF INFECTION. THERE WAS NO REPORT OF ANY HARM. THIS EMDR IS ONE OF 3 EVENTS/OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300477 ↗
• MalfunctionMay 19, 2026Crack; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH WHERE IT WAS REPORTED THAT A COUPLE OF INCIDENTS INVOLVING A POTENTIAL LEAK FROM THE FILTER ON THE PRIMARY PLUM SET OCCURRED DURING HAZARDOUS DRUG INFUSIONS ON 04-02 (PACLITAXEL) AND 04-21 (POLATUZUMAB). BOTH EVENTS INVOLVED PERIPHERAL INFUSIONS RESULTING IN LEAKAGE OF HAZARDOUS DRUG WITH EXPOSURE TO BOTH THE PATIENT AND STAFF REQUIRING MEDICATION REMAKE AND LEADING TO DRUG WASTAGE. THE LEAK WAS ASSOCIATED WITH THE FILTER, WITH ONE INSTANCE INVOLVING A HOLE WHILE THE OTHER INVOLVED A SUSPECTED CRACK. ONE FILTER WAS CONFIRMED CRACKED WHEREAS THE OTHER SHOWED NO APPARENT VISIBLE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219444 ↗
• MalfunctionMay 19, 2026Crack; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH WHERE IT WAS REPORTED THAT A COUPLE OF INCIDENTS INVOLVING A POTENTIAL LEAK FROM THE FILTER ON THE PRIMARY PLUM SET OCCURRED DURING HAZARDOUS DRUG INFUSIONS ON (B)(6) (PACLITAXEL) AND 04-21 (POLATUZUMAB). BOTH EVENTS INVOLVED PERIPHERAL INFUSIONS RESULTING IN LEAKAGE OF HAZARDOUS DRUG WITH EXPOSURE TO BOTH THE PATIENT AND STAFF REQUIRING MEDICATION REMAKE AND LEADING TO DRUG WASTAGE. THE LEAK WAS ASSOCIATED WITH THE FILTER, WITH ONE INSTANCE INVOLVING A HOLE WHILE THE OTHER INVOLVED A SUSPECTED CRACK. ONE FILTER WAS CONFIRMED CRACKED WHEREAS THE OTHER SHOWED NO APPARENT VISIBLE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219439 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  EVENT OCCURRED REGARDING A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH WHERE IT WAS REPORTED THAT A CHEMO LEAK (OR) SPILL FROM THE FILTER ON THIS PRODUCT WAS NOTED. PATIENT INVOLVEMENT AND HARM ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207585 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  AN EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH WHERE IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE AIR VENT HOLE OF THE RECTANGULAR FILTER. DURING THE LEQEMBI INFUSION, A SMALL AMOUNT OF LEAKAGE WAS OBSERVED WHEN FLUID DRIPPED ONTO THE PATIENT¿S PANTS AND DURING THE KISUNLA INFUSION, A MORE SIGNIFICANT LEAKAGE WAS NOTED, ESTIMATING APPROXIMATELY 5 ML OF FLUID LOSS, IT WAS DELIVERED AT THE RATE OF 277 ML/HR. THE DRUG WAS INFUSED VIA PERIPHERAL AND THE CONCENTRATION WAS860 MG IN 250 ML (3.44 MG/ML). THE LEAKAGE BEGAN ALMOST IMMEDIATELY AFTER THE INFUSION WAS INITIATED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180280 ↗
• MalfunctionMay 6, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH, ALLEGING THAT THE TUBING MAY HAVE BEEN LEAKING NEAR THE FILTER AREA. THE BABY'S ISOLETTE WAS OPENED AND THE SMELL OF TOTAL PARENTAL NUTRITION (TPN) WAS NOTED. THE INTRAVENOUS (IV) FLUID TUBING WAS LEAKING TPN. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105997 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH WHERE IT WAS REPORTED THAT THE TAXOL TUBING WAS LEAKING AT THE FILTER SITE. THE EVENT OCCURRED AT THE END OF INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973913 ↗
• MalfunctionApr 20, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH AND IT WAS REPORTED THAT THE PATIENT HAD AN EPOCH (DOXORUBICIN, ETOPOSIDE OR VEPESID, VINCRISTINE SULPHATE) BAG HUNG AT 6:44PM USING ICU MEDICAL PRIMARY PLUM SET TUBING WITH A 0.2-MICRON FILTER. ON THE FOLLOWING DAY, AROUND 6:30PM, WHEN THE REGISTERED NURSE TOOK THE EPOCH BAG DOWN, THE ABDOMINAL PAD THAT HAD BEEN WRAPPED AROUND THE FILTER BY THE RN WHO HAD HUNG THE BAG WAS EXAMINED, AND IT WAS NOTED TO HAVE 2 DROPS OF CHEMOTHERAPY ON THE PAD. THE ENTIRE SETUP WAS PLACED INTO A CHEMO BAG AND WAS RETURNED TO THE PHARMACY. THERE WAS PATIENT INVOLVEMENT, AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922428 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED WITH AN ATTACHED MEDWATCH REPORT NUMBER MW5184335 WITH REGARDS TO A PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH, IN WHICH IT WAS REPORTED THAT DURING THE FIRST DOSE OF FAM-TRASTUZUMAB DERUXTECAN INFUSION AND AFTER ONLY 1.7ML INFUSED OF THE PRIMED VOLUME A LEAK OCCURRED AT THE FILTER SITE. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772274 ↗

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-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-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-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