Plum 1425428Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10887787006039), received between Sep 20, 2019 and Mar 10, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (33 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Fluid/Blood Leak

  The event occurred on an unknown date involving a Primary PLUM Set, CLAVE Secondary Port, 2 CLAVE Y-Sites, 0.2 Micron Filter, Secure Lock, 112 Inch. It was reported that the device was leaking at the filter on the Total Parenteral Nutrition (TPN) tubing. No reported patient involvement and harm. There was patient involvement and no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24564958 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON TWO SEPARATE OCCASIONS, TAXOL REPORTEDLY LEAKED FROM THE FILTER SITE OF THE PRIMARY TUBING (SPECIFICALLY AT THE CIRCULAR AREA ON THE BOTTOM OF THE FILTER) OF PRIMARY PLUM SETS, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. THE REPORTER STATED THAT A PATIENT WAS RECEIVING A 24-HOUR CONTINUOUS INFUSION OF TAXOL ON DAY 1 OF THE TIP [TAXOL (PACLITAXEL), IFOSFAMIDE, AND PLATINOL (CISPLATIN)] REGIMEN. BOTH TIMES, THE LEAK OCCURRED AT ROUGHLY THE 19-HOUR MARK, PRIOR TO COMPLETION OF THE 24-HOUR INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350115 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH WHERE IT WAS REPORTED THAT THE DEVICE HAS LEAKED FROM THE FILTER. THE DRUG INVOLVED WAS PACLITAXEL. THE PATIENT INVOLVEMENT AND PATIENT HARM WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294033 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA A MEDSUN MANDATORY MEDWATCH REPORT THAT ON, AN UNSPECIFIED DATE IN (B)(6), A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH GENERATED A LEAK DURING PATIENT USE. THE B-PORT ON THE PRIMARY TUBING CONNECTED TO A CHEMOLOCK WAS FOUND TO BE LEAKING ONCE THE SECONDARY LINE WAS RUNNING WITH THE FLUOROURACIL. THE INFUSION WAS STOPPED, TRIED RETIGHTENING THE CONNECTION, DISCONNECTED, AND RECONNECTED THE CHEMOLOCK. THE MEDICATION CONTINUED TO LEAK FROM UNDER THE CL2100 DEVICE. THE B-PORT HUB STAYED DEPRESSED WHEN THE CONNECTION WAS REMOVED. THE ORIGINAL INTENDED PROCEDURE WAS CHEMOTHERAPY INFUSION. SET, ADMINISTRATION, INTRAVASCULAR. THIS IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THIS DEVICE IS AVAILABLE FOR EVALUATION. THIS TYPE OF REPORT IS A PRODUCT PROBLEM. THIS TYPE OF REPORTABLE EVENT IS A MALFUNCTION. THIS IS AN INITIAL TYPE OF REPORT. THIS REPORT WAS SENT TO MANUFACTURER. THE INITIAL REPORTER IS (B)(6). A BIOMEDICAL ENGINEER AND HEALTH PROFESSIONAL FROM MEMORIAL CARE. THE CONTACT PERSON IS (B)(6) FROM (B)(6) MEDICAL CENTER. THE LOCATION WHERE THE EVENT OCCURRED WAS AT THE HOSPITAL AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457041 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA A MEDSUN MEDWATCH MANDATORY THAT, ON AN UNSPECIFIED DATE IN MAY, A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH, GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED: THE CONNECTION BETWEEN THE SECONDARY CLAVE AND THE CHEMO LOCK CL2100 CAUSED LEAKING WHEN CHEMO WAS INFUSING. THE SPILLS WERE SMALL AND CLEANED. THE AREA WAS SANITIZED. THE SPILL WAS NOTED TOWARD THE END OF THE PATIENT'S TREATMENT. THE EVENT OCCURRED AT THE HOSPITAL USER FACILITY. THE ORIGINAL INTENDED PROCEDURE WAS CHEMOTHERAPY INFUSION. THERE IS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453025 ↗
• MalfunctionSep 17, 2024Air/Gas in Device; Air/Gas in Device

  AN COMPLAINT INVOLVING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH EXPERIENCED AIR IN LINE. IT WAS STATED IN THE REPORT THAT THE EVENT OCCURRED WHEN SETTING UP THE IV PUMP FOR INFUSION. RN PRIMED FILTER TUBING WITH PANITUMUMAB MED, PUT TUBING IN IV PUMP, TURNED PUMP ON, PUMP WENT THROUGH ITS INITIAL CHECKS AND ALARMED "DISTAL AIR". RN DISCOVERED THE DRIP CHAMBER HAD FILLED ALL THE WAY UP, THEY ONLY FILLED HALFWAY, THIS HAPPENED WITH AN ALREADY REPORTED INCIDENT AS WELL, THERE WAS VISIBLE AIR IN THE TUBING BELOW THE CASSETTE (DISTAL). RN ALSO NOTICED ON THE CASSETTE, THE BLUE PORT ON THE CASSETTE LOOKED DIFFERENT. THE CENTER SILICONE CIRCLE WAS ELEVATED UP OVER THE BLUE PORT TOP. THIS IS NOT HOW THE TUBING USUALLY LOOKS. IT WAS REMOVED FROM THE IV PUMP AND SENT UP TO PHARMACY TO PUT ON NEW TUBING. PATIENT CARE WAS DELAYED AS THE ENTIRE SET HAD TO BE SENT BACK UP TO PHARMACY, THEY HAD TO PUT A NEW TUBING ON DRUG BAG AND THEN TUBING WAS REPRIMED AND SENT BACK DOWN TO INFUSION DEPARTMENT. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242990 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. IT WAS STATED THAT LOT NUMBER SEEMED TO HAVE A SMALL CUT IN THE LINE BELOW THE FILTER AND SALINE SQUIRTED OUT WHEN STAFF PRIMED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076440 ↗
• MalfunctionAug 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON 22-JUL-2024 TO 25-JUL-2024 INVOLVING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH IT WAS STATED THAT THE PRODUCT WAS LEAKING WITH A MEDICATION OF DOXORUBICIN. THE EVENT OCCURRED DURING INFUSION. THE DOXORUBICIN IS IN EPOCH (ETOPOSIDE, VINCRISTINE, DOXORUBICIN). RITUXIMAB WITH ANOTHER RESEARCH STUDY MEDICATION WAS DISPENSED WITH PRIMARY PLUM SET TUBING AND A SPIROS ATTACHED ON THE END OF THE PRIMARY TUBING SET. LEAKAGE OCCURRED DUE TO THE SPIROS DISENGAGING FROM THE PRIMARY TUBING. ANOTHER INCIDENT WITH THE SPIROS WAS CHECKED BEFORE INFUSING AND IT WAS ABLE TO BE REMOVED FROM THE PRIMARY TUBING. THE SPIROS WAS REPLACED WITH A NEW SPIROS AND CONNECTED TO THE PRIMARY LINE. THE SPIROS WAS CHECKED BEFORE INFUSING AND IT WAS ABLE TO BE REMOVED FROM THE PRIMARY TUBING. THE SPIROS WAS REPLACED WITH A NEW SPIROS AND CONNECTED TO THE PRIMARY LINE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY BECAUSE THEY NEEDED TO STOP DUE TO LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20058490 ↗
• MalfunctionAug 23, 2024Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  THE EVENT OCCURRED ON (B)(6) 2024 AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH WHERE IT WAS REPORTED THE PRODUCT WAS LEAKING DURING INFUSION. IT WAS STATED THERE WAS A CONTINUOUS INFUSION OF ETOPOSIDE IN EPOCH (ETOPOSIDE, VINCRISTINE, DOXORUBICIN) DISPENSED WITH PRIMARY PLUM SET TUBING W/ 0.2-MICRON FILTER WHICH BECAME DETACHED AT THE SITE WHERE THE PRIMARY TUBING AND THE SPIROS CONNECT. THIS CAUSED LEAKAGE OF PATIENT BLOOD AND CHEMO. THE SPIROS REMAINED ATTACHED TO THE PATIENT¿S PORTACATH BUT THE PRIMARY TUBING WAS DETACHED AND LEAKED CHEMO ON THE FLOOR AND BED. LEAK WAS ESTIMATED AT 30ML, MIXTURE OF BLOOD AND CHEMOTHERAPY. CODE ORANGE (HAZARDOUS SPILL) WAS CALLED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY BECAUSE THEY NEEDED TO STOP DUE TO LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051045 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. THE PRODUCT WAS REPORTEDLY LEAKING OXALIPLATIN DURING THE LAST FEW MINUTES OF INFUSION. THE ISSUE/EVENT OCCURRED SOMETIME BETWEEN 22-JUL-2024 AND 25-JUL-2024. OXALIPLATIN WAS AT THE Y-SITE INTO A D5W PRIMARY LINE AND THE SPIROS THAT ATTACHES TO THE PATIENT BEGAN TO LEAK AT THE SITE WHERE THE PRIMARY TUBING AND THE SPIROS CONNECT. THERE WAS NO PATIENT HARM; HOWEVER, THERE WAS A DELAY IN THERAPY BECAUSE THEY NEEDED TO STOP THE INFUSION DUE TO LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026561 ↗
• MalfunctionJun 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON A UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 WHERE IT WAS REPORTED THAT LEAKING OCCURRED. NO OTHER INFORMATION WAS PROVIDED ON THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611360 ↗
• MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. THE CUSTOMER REPORTED THAT THEY HAD A RECENT UNSPECIFIED CHEMOTHERAPY SPILL FROM A LEAK AROUND THE CLAVE OF THE DEVICE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582301 ↗
• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH WHERE THE CUSTOMER REPORTED THAT 1.5HRS INTO PACLITAXEL INFUSION, A NURSE (RN) OBSERVED DROPLETS ON PACLITAXEL FILTER. THE INFUSION WAS PAUSED. ON ASSESSMENT, THE PATIENT DID NOT HAVE ANY DAMP/WET AREAS ON CLOTHING OR SKIN. WHEN TAXOL FILTER WRAPPED WITH BLUE PAD, PAD BECAME DAMP. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524874 ↗
• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH WHERE IT WAS REPORTED LEAKING OCCURRED ON PACLITAXEL FILTER DURING AN INFUSION. INFUSION WAS PAUSED. ON ASSESSMENT, PATIENT DID NOT HAVE ANY DAMP/WET AREAS ON CLOTHING OR SKIN. WHEN TAXOL FILTER WRAPPED WITH BLUE PAD, PAD BECAME DAMP. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522477 ↗
• MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH AND WAS RECEIVED FROM A SR. SPECIALIST, POST MARKET VIGILANCE OF CARDINAL HEALTH/DISTRIBUTOR. THE CUSTOMER REPORTED THAT THE DEVICE LEAKED AT THE FILTER DURING CHEMOTHERAPY (UNSPECIFIED) INFUSION. THE LEAK WAS DESCRIBED AS CONDENSATION AROUND THE FILTER WITH A FEW DROPS SURROUNDING THE FILTER. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397641 ↗
• MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH IT WAS STATED THAT THE FACILITY HAS EXPERIENCED A TOTAL OF 3 FILTER LEAKS FOR BOTH INPATIENT UNITS AND CHEMO SUITES. THE LEAKS WERE DESCRIBED AS MORE OF A CONDENSATION AROUND THE FILTER WITH A FEW DROPS SURROUNDING THE FILTER. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THERE WERE A TOTAL OF THREE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390947 ↗
• MalfunctionMay 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED AN UNSPECIFIED TUBING SET. THE TUBING WAS REPORTEDLY LEAKING AT THE IN-LINE FILTER DURING A PATIENT'S INFUSION. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377111 ↗
• MalfunctionJan 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH WHERE IT WAS REPORTED THERE WAS LEAKAGE FROM INTRAVENOUS TUBING TO THE SITE OF THE DROPLET FILTER. THE PATIENT NOTED A COLD AND DAMP SENSATION ON HER ARM AND THE NURSE NOTED THE PRESENCE OF A DRIP FROM THE FILTER USED FOR THIS MEDICATION. THE PATIENT DID COME INTO CONTACT WITH A SMALL AMOUNT OF CHEMO (A FEW DROPS). THE HEALTHCARE PROVIDER WAS WEARING THEIR PROTECTIVE EQUIPMENT (EPI) AND DID NOT HAVE DIRECT CONTACT WITH THE LEAKING CYTOTOXIC DRUG. THE PATIENT¿S SKIN WAS CLEANED WITH WATER AND SOAP. THE PATIENT HAD CONTACT ON THEIR RIGHT FOREARM WITH A FEW DROPS. THE HEALTHCARE PROVIDER HAS NOT BEEN EXPOSED TO CHEMOTHERAPY DRUGS IN AN UNPROTECTED MANNER. THE PROCEDURE OF SPILLAGE FOR SUCH AN INCIDENT HAS BEEN FOLLOWED, WHICH INCLUDED A CONTACT OF THE CHEMOTHERAPY AGENT WITH THE PATIENT¿S SKIN AND THE CLEANING TEAM SUBSEQUENTLY HANDLED THE CLEANUP. A SPILL KIT WAS USED. THERE WERE NO VISIBLE HOLES, CUTS, OR TEARS. HOWEVER, A VERY SLIGHT LEAK OCCURRED AT THE END OF THE INFUSION THROUGH THE FILTER CASSETTE, CLOSEST TO THE PATIENT. THE

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579846 ↗
• MalfunctionJan 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH GENERATED A LEAK. THE PATIENT WAS PLACED ON A NORMAL SALINE (NS) FLUSH POST PACLITAXEL INFUSION WHEN THE REGISTERED NURSE (RN) NOTED THE FILTERED TUBING LEAKING AT THE POSTERIOR SIDE WITH 2 DROPS OF CLEAR FLUID NOTED ON THE PATIENT'S SWEATER. THE PATIENT'S SWEATER WAS REMOVED AND PLACED INTO A CLEAR GARBAGE BAG, AND WASHING INSTRUCTIONS WERE GIVEN TO THE PATIENT'S DAUGHTER. NO MOISTURE WAS NOTED ON THE PATIENT'S SHIRT UNDERNEATH OR HER SKIN. THE PATIENT¿S TUBING WAS CHANGED FOR CARBOPLATIN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509329 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH ARE GENERATING LEAKING IN HIGH FREQUENCY IN THE CHEMO SUITES. DURING PATIENT USE. THE MEDICATION INVOLVED WAS MANNITOL. THERE WERE NO HOLES, CUTS, TEARS OR ANY DEFECTS NOTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460894 ↗
• MalfunctionDec 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH WHERE IT WAS REPORTED THERE WAS A RED COLORED TAINTED COLOR INSIDE STERILE INTRAVENOUS TUBING. THE ISSUE WAS NOTED WHEN PUTTING SPIKE INTO BAG, IT WAS NOTED DURING INITIAL SET-UP/PRIMING. THIS IS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED ON A PATIENT. THE EVENT DID NOT OCCUR WHILE THE PRODUCT WAS IN USE WITH A PATIENT. THERE WAS NO ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410844 ↗
• MalfunctionDec 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH SETS ARE LEAKING IN HIGH FREQUENCY IN THE CHEMO SUITES DURING PATIENT USE. THE MEDICATION INVOLVED WAS PACLITAXEL. THERE WERE TWO DROPS ON THE PATIENT, DROPS WERE ABSORBED ONTO A BLUE PAD, THE PATIENT'S SKIN WAS CLEANSED, AND INSTRUCTIONS WERE PROVIDED FOR LAUNDERING CLOTHING. THE CHEMO DRUG CAME INTO CONTACT WITH CLOTHING. THERE WAS UNPROTECTED CHEMODRUG EXPOSURE TO THE PATIENT. THE CHEMO DRUG SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WERE NO HOLES, CUTS, TEARS, OR ANY DEFECTS NOTED. THE AFFECTED SAMPLE WAS ATTACHED TO A TUBING SET WITH A CLOSED SYSTEM TRANSFER DEVICE - CHEMOLOCK. IT WAS ALSO STATED THAT THE CHEMO WAS COMING OUT OF THE TWO CIRCLES ON THE BACK OF THE FILTER CASE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390052 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. AS PER REPORT, PATIENT NOTICED DURING DURVALUMAB INFUSION THAT HER ARM WAS WET. UPON FURTHER INSPECTION, A SMALL HOLE ON THE BACK OF THE FILTER AT THE MOST DISTAL END WAS SPURTING FLUID. THIS WAS NOT A CRACK, AS THE HOLE IS PART OF EVERY FILTER, HOWEVER, IT SHOULD NOT HAVE BEEN LEAKING. INFUSION PAUSED AND SKIN DRIED AND CLEANED. TEAM LEAD WAS NOTIFIED. SHE CALLED PHARMACY WHO MADE A NEW BAG WITH THE REMAINING DOSE THAT HAD NOT YET BEEN INFUSED (PATIENT HAD RECEIVED 163ML OF A 305.5ML BAG). A NEW FILTER LINE WAS ATTACHED BELOW THE CURRENT LEAKING SITE ON THE CURRENT LINE (WHICH WAS CLAMPED) AND THE NEW DRUG WAS RAN THROUGH THE NEW LINE. MEDICAL INTERVENTION WAS NOT REQUIRED. INTUBATION WAS NOT NECESSARY. THERE WERE NO UNUSUAL CIRCUMSTANCES. THE DEVICE WAS NOT RE-STERILIZED OR RE-PROCESSED. THE DEVICE WAS NOT PRE-TESTED PRIOR TO USE. SECOND DEVICE WAS NOT REQUIRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317660 ↗
• MalfunctionDec 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. THE REPORTER NOTICED THAT THE PATIENT'S T SHIRT WAS WET DURING INFUSION OF CISPLATIN AND MANNITOL. UPON FURTHER INSPECTION, IT WAS OBSERVED THAT MANNITOL WAS LEAKING FROM THE FILTER BOX. THE CHARGE NURSE (CARMEN) CHANGED THE FILTER LINE AND DECREASED THE VOLUME FOR THE INFUSION WITH THE SMALL TUBING S/L IN CASE IT COULD HAVE CONTRIBUTED TO IT. MEDICAL INTERVENTION WAS NOT REQUIRED AND INTUBATION WAS NOT NECESSARY. THERE WERE NO UNUSUAL CIRCUMSTANCES AND NO PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307878 ↗
• MalfunctionDec 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH. AS PER THE REPORT, THERE WAS CHEMOTHERAPY LEAKING FROM THE FILTER. THE EVENT OCCURRED DURING USE ON A PATIENT. THE PRODUCT WAS USED FOR 1 HOUR WHEN THE PATIENT NOTED LEAKING ON THE CHAIR SIDE TABLE. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT, AND THERE WAS A DELAY IN THERAPY. NO ADVERSE EVENT REPORTED AND THERE WAS NO PATIENT HARMED AS A RESULT OF THE REPORTED EVENT. THIS IS THE SECOND OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293100 ↗

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-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