Plum 1955488Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787008774), received between Jul 16, 2023 and Jul 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PRIMARY PLUM SET, 1.2 MICRON FILTER, SECURE LOCK, 119 INCH AND OCCURRED ON AN UNSPECIFIED DATE. THE REPORT STATES THAT THE FILTER AND LINE LEAKING WHERE FILTER IS IN THE MIDDLE OF THE LINE. THE LEAK OCCUR NEAR THE CIRCLE AREAS ON THE BLUE FILTER. TOTAL PARENTERAL NUTRITION IS BEING INFUSED (LIPIDS, DEXTROSE, AMINO ACID SOLUTIONS) AND LINE WAS INFUSING TO PATIENT WHEN LEAKS OCCURRED. NO ADVERSE HARM BUT DISRUPTION TO PATIENT CARE.THE TOTAL PARENTERAL NUTRITION BAG MUST BE DISCARDED AS IT CANNOT BE RESPIKED. THE PATIENT THEN HAS NO NUTRITION FOR UP TO 24 HOURS AS THE TPN BAG IS CUSTOMIZED FOR THE INDIVIDUAL PATIENT AND A NEW BAG CANNOT BE RECEIVED UNTIL A NEW ONE IS ORDERED AND DELIVERED. THERAPY CANNOT BE RESUMED UNTIL A NEW BAG OF TPN IS PROVIDED. TPN BAG CANNOT BE RESPIKED WITH A NEW FILTER AS TPN BAG IS NOT DESIGNED TO HAVE MULTIPLE SPIKES. NO HOLE, CUT, TEARS OR ANY DEFECT OBSERVED PRIOR TO USING THE FILTER. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330960 ↗

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-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