Plum 1424228Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887787006237), received between Aug 7, 2018 and Jul 11, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023No Flow; No Flow

  THE EVENT INVOLVED A PLUM 360 PUMP AND OCCURRED ON AN UNSPECIFIC DATE. IT WAS REPORTED THAT THEY ATTEMPTED RUNNING DIFFERENT PLUM SETS OUT OF THIS ORDER AND NONE WILL RUN IV FLUID THROUGH OUR PUMPS. A SERVICE TECHNICIAN CAME TO OUR FACILITY TO RUN DIAGNOSTICS ON OUR PLUM PUMPS TO MAKE SURE IT WASN¿T THE PUMP MALFUNCTIONING. HE RAN HIS OWN PLUM SET TUBING THROUGH OUR PUMPS, AND HIS TUBING DID NOT MALFUNCTION. THE RECENT ORDER I RECEIVED MAKES THE PUMP THROW AN ERROR CODE ON START-UP OF THE PLUM PUMP. MULTIPLE SAMPLES WERE TESTED, AN ESTIMATE OF 10-15 SAMPLES, WITH FOUR DIFFERENT PUMPS BUT THE ERROR PERSISTS. THE TECHNICIAN TRIED USING A DIFFERENT CASSETTE TO THOSE PUMPS AND THEY WORKED FINE. THE AFFECTED SAMPLES WERE ALREADY DISCARDED BUT SISTER SAMPLES OF THE SAME LOT ARE AVAILABLE FOR EVALUATION. ADDITIONALLY, IT WAS STATED THAT PATIENT INVOLVEMENT HAPPENS WHEN THEY ARE NOT ABLE TO INITIATE HYDRATION OR MEDICATION DELIVERY THROUGH THE PLUM PUMP. THEY WERE USING PLUM A+ PUMPS. THE ERROR CODE IS LISTED IN THE PLUM PUMP MANUAL AS N185. THE ERROR MESSAGE READS AS: ¿PROXIMAL OCCL A AT START UP.¿ ON THE EVALUATION REPORT BY MEDICAL EQUIPMENT SERVICES, IT STATED THAT THEY TRIED DIFFEREN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299994 ↗
• MalfunctionJul 20, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH WHERE IT WAS REPORTED THAT THERE WERE AIR BUBBLES IN THE TUBING DURING INFUSION. THE PRIMARY TUBING WAS PRIMED AND CONNECTED TO THE PATIENT WHEN AIR BUBBLES WAS NOTED ABOUT TWO INCHES LONG. THE NURSES REPLACED THE TUBING AND ATTACHED TO PATIENT WITH NO OTHER ISSUE FOR THE REST OF THE INFUSION. IT WAS ALSO REPORTED THAT THEY DID NOT HAVE ISSUES WITH THE UNSPECIFIED ICU MED PUMP THAT WAS USED BECAUSE THEY WERE ABLE TO REDO THE PROCESS AND CHANGED THE TUBING. THERE WAS PATIENT INVOLVED BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065867 ↗
• MalfunctionJul 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH WHERE IT WAS REPORTED THAT THE CUSTOMER FOUND AN IV PRIMARY TUBING SET THAT HAD DIRT SPECKS IN THE CASSETTE. THERE WERE 2 PIECES OF DIRT IN THE CASSETTE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013770 ↗
• MalfunctionApr 11, 2019Particulates; Particulates

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A ¿SPECK¿ OF SOMETHING WAS NOTICED TO BE IN THE PLASTIC OF THE DRIP CHAMBER. THE REPORTER STATED, THEY COULD NOT TELL IF IT IS PART OF THE PLASTIC OR IF IT IS LOOSE IN THE CHAMBER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8504987 ↗
• MalfunctionOct 15, 2018Material Split, Cut or Torn

  RN HUNG NEW PRIMARY IV TUBING, PATIENT CALLED OUT SHORTLY AFTER HUNG STATING HIS IV WAS BLEEDING. RN NOTED IV WAS INTACT AND WORKING PROPERLY. UPON INSPECTION OF THE TUBING THERE WAS A SMALL SLIT IN THE TUBING ABOUT 4 INCHES FROM WHERE IT CONNECTS TO THE SALINE LOCK. BLOOD HAS BACKED UP TO THE SLIT AND WAS LEAKING OUT OF THE TUBING. 3 PACKAGE LABELS FOUND IN THE MED ROOM. ONE OF WHICH IS FOR THIS TUBING PER RN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7964696 ↗
• MalfunctionAug 7, 2018Material Fragmentation

  WHILE SETTING UP INFUSION FOR PATIENT AND THE CASSETTE PORTION OF THE IV BROKE INTO PIECES. THE STAFF DID NOT GIVE ANY MORE INFORMATION THAN WHAT WAS PROVIDED. IT APPARENTLY HAPPENED ON MORE THAN ONE OCCASION. THEY CHANGED SETS AND CONTINUED THE CARE THEY WERE PROVIDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756336 ↗

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-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-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-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