Plum 1421228Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10887787006428), received between Jan 4, 2024 and Sep 29, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 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 50937656 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak; Free or Unrestricted Flow; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934694 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652297 ↗
• MalfunctionNov 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH WHICH WAS FOUND TO BE LEAKING. IT WAS REPORTED THAT AFTER PRIMING THE TUBING TO START BLOOD TRANSFUSION, THE BOTTOM OF THE DRIP CHAMBER WAS FOUND TO BE CRACKED AND LEAKING BLOOD. THE TUBING WAS SWITCHED OUT; BLOOD TRANSFUSION WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529378 ↗
• MalfunctionNov 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A PRIMARY PLUM Y-TYPE BLOOD SET THAT WAS REPORTED THAT THE BLOOD FILTER CRACKED AT FILTER, BLOOD DRIPPED OUT. THIS OCCURRED 20 MIN INTO INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528874 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT WHEN THE PATIENT WAS RECEIVING A BLOOD AND WHEN THE NURSE SQUEEZED THE CHAMBER ABOUT 1/4 FULL, IT WOULD CRACK, CAUSING BLOOD TO LEAK ON THE FLOOR AND THE EQUIPMENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572138 ↗
• MalfunctionJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH WHERE THEY REPORTED THAT THEY ARE EXPERIENCING LEAKING IN THE ADMINISTRATION SET AT THE BOTTOM ON THE FILTER. THE REPORTED ALSO STATED THAT THERE HAVE BEEN 2 REPORTED INCIDENTS OF LEAKING TUBING. THE FIRST WAS IDENTIFIED DURING THE PRIMING OF THE SET AND RESULTED IN THE LOSS OF A UNIT OF BLOOD. THE SECOND WAS IDENTIFIED BY THE NURSE WHO INSPECTED THE PRODUCT PRIOR TO THE NURSE SPIKING THE BLOOD BAG. IT WAS IDENTIFIED DURING BLOOD TRANSFUSION AND RESULTED IN THE LOSS OF A UNIT OF BLOOD AND A DELAY IN CARE. THE BLOOD WAS INFUSING AT THE RATE OF 125ML/HR. AND THE LEAK WAS IN THE FILTER CHAMBER. THEY STATED THAT THE LEAKS ON BOTH SETS OCCURRED IN THE BOTTOM OF THE DRIP CHAMBER AT THE WELD BETWEEN THE CLEAR PLASTIC SIDEWALLS OF THE DRIP CHAMBER AND THE WHITE HARD PLASTIC BASE OF THE DRIP CHAMBER. THERE WAS NO ADVERSE EVENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519174 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH. LEAKAGE WAS REPORTED UNDER THE FILTER CHAMBER DURING A BLOOD TRANSFUSION OF PACKED RED BLOOD CELLS. FOR THIS INCIDENT, THE RN NOTICED THE PROBLEM WHEN THE BLOOD PRODUCT HAD JUST BEEN INITIATED. THERE WAS NO ADVERSE EVENT OR HARM; HOWEVER, THERE WAS DELAY IN THERAPY WHEN THEY HAVE TO RE-PRIME ANOTHER TUBING SET. THE BLOOD THAT WAS PRIMED IN THE OTHER SET WAS TECHNICALLY WASTED AND THE PATIENT DID NOT RECEIVE IT. THIS REPORT REFLECTS THE 2ND OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159379 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH. LEAKAGE WAS REPORTED UNDER THE FILTER CHAMBER DURING A BLOOD TRANSFUSION OF PACKED RED BLOOD CELLS. FOR THIS INCIDENT, THE PATIENT WAS AWAKE AND NOTIFIED THE RN THAT THERE WAS BLOOD DRIPPING OUT OF THE TUBING. THERE WAS NO ADVERSE EVENT OR HARM; HOWEVER, THERE WAS DELAY IN THERAPY WHEN THEY HAVE TO RE-PRIME ANOTHER TUBING SET. THE BLOOD THAT WAS PRIMED IN THE OTHER SET WAS TECHNICALLY WASTED AND THE PATIENT DID NOT RECEIVE IT. THIS REPORT REFLECTS 1 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159202 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH WHERE IT WAS REPORTED THAT THE PRODUCT WAS LEAKING BEFORE THE FILTER. THE QUANTITY OF THE AFFECTED DEVICE WAS 2. THE PRODUCT WAS NOT REPROCESSED IN ANY WAY. THE DEVICE FAILS TO FUNCTION/DEFECTIVE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM REPORTED. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500834 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THERE WAS LEAKING BLOOD IN THE CARTRIDGE, IT CONTAMINATED THE INTRAVENOUS (IV) PUMP, AND IT MAY HAVE RESULTED IN CONTAMINATION TO THE PATIENT. THE PATIENT NEEDED ADDITIONAL INTERVENTION TO PREVENT HARM. THEY WERE UNABLE TO DO A BLOOD TRANSFUSION RESULTING IN THE PATIENT NOT GETTING THE NECESSARY BLOOD FOR FOUR DAYS. THEY HAD TO DISCARD THE UNIT OF BLOOD THAT THE PATIENT NEEDED AND THE TUBING. IT TOOK OVER FOUR DAYS TO GET THE BLOOD TYPE FOR THE PATIENT. THEY HAD TO PUT THE PATIENT ON ANTIBIOTICS FOR CLOSER TO 10 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802818 ↗
• InjuryJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THERE WAS LEAKING BLOOD IN THE CARTRIDGE, IT CONTAMINATED THE INTRAVENOUS (IV) PUMP, AND IT MAY HAVE RESULTED IN CONTAMINATION TO THE PATIENT. THE PATIENT NEEDED ADDITIONAL INTERVENTION TO PREVENT HARM. THEY WERE UNABLE TO DO A BLOOD TRANSFUSION RESULTING IN THE PATIENT NOT GETTING THE NECESSARY BLOOD FOR FOUR DAYS. THEY HAD TO DISCARD THE UNIT OF BLOOD THAT THE PATIENT NEEDED AND THE TUBING. IT TOOK OVER FOUR DAYS TO GET THE BLOOD TYPE FOR THE PATIENT. THEY HAD TO PUT THE PATIENT ON ANTIBIOTICS FOR CLOSER TO 10 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590517 ↗
• MalfunctionJan 4, 2024Break; Break

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE LOCK, 110 INCH, WHERE IT WAS REPORTED A NURSE WAS ATTACHING A SYRINGE TO THE BLUE CLAVE THAT'S BONDED TO THE CASSETTE, AND THE SMALL HARD PLASTIC TUBE BETWEEN THE CLAVE AND CASSETTE SNAPPED OFF. THE REGISTERED NURSE STATED IT SNAPPED OFF EASILY WHEN SHE STARTED TWISTING ON THE SYRINGE. THE EVENT OCCURRED DURING INFUSION; THE NURSE WAS SETTING UP THE FLUSH SO THE PATIENT COULD RECEIVE THE LAST 20 ML OF PRODUCT. THE NURSE QUICKLY DISCONNECTED THE TUBING FROM THE PATIENT. THE PATIENT WAS JUST NOT ABLE TO RECEIVE THE LAST 20 ML OF THEIR TRANSFUSION. THERE WAS PATIENT INVOLVEMENT, AND IT WAS UNKNOWN IF THERE WAS PATIENT HARM AS THE INCIDENT RESULTED IN AN OPEN LINE TO THE PATIENT¿S VEIN. MOREOVER, THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445887 ↗