Plum 1187912Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887787009023), received between Jan 29, 2019 and Jun 9, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 29, 2019Terminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0126-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT REPORTED IS A PLUM SET WITH CONTAMINANT IN INFUSION TUBING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134055 ↗
• MalfunctionJun 4, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVES A PLUM SET THAT WAS REPORTED ORANGE LIQUID FLOWED OUT WHEN INFUSING NORMAL SALINE. THE CUSTOMER STATED THEY SUSPECT DYE IN TUBING IS RUNNING OUT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118931 ↗
• MalfunctionAug 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PHYXOL INFUSION WAS STARTED ON (B)(6) 2019 AND ON (B)(6) 2019 THE DEVICE BEING USED WAS FOUND LEAKING THE MEDICATION WITH 10 ML OF DRUG LEFT IN THE BAG. TRACES OF THE MEDICATION LEAK WERE FOUND ON THE PATIENT¿S CLOTHING. IT WAS REPORTED THAT THE PATIENT FOUND THE BED RAIL WET ON THE MORNING OF (B)(6) 2019. THERE WAS NO HARM TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Chemical Exposure

  MAUDE report 8927258 ↗
• MalfunctionJul 30, 2019Particulates; Particulates

  THE EVENT INVOLVED A PLUM SET THAT THE CUSTOMER REPORTED AN IMPURITY (HAIR) INSIDE THE CASSETTE. THE EVENT OCCURRED ON AN UNKNOWN DATE. NO MORE INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842212 ↗
• MalfunctionMay 31, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A PLUM SET WITH LEAKAGE ON THE FILTER. THIS RECORD CAPTURES THE SECOND OF TWO DEVICES. THE REPORTED FILTER LEAK WAS CONFIRMED BY INVESTIGATION. ONE (1) USED LIST PLUM SET WAS RECEIVED FOR INVESTIGATION. AS RECEIVED, THE RETURNED SET WAS VISUALLY INSPECTED AND THE FILTER VENT WAS OBSERVED TO BE WETTED AND/OR SATURATED. THE REPORTED INFUSATE WAS TAXOL. THE RETURNED SET WAS LEAK TESTED PER THE PRODUCT SPECIFICATIONS AND A LEAK WAS OBSERVED FROM THE FILTER VENT OF THE FILTER OF THE RETURNED SETS. RED DYED WATER WAS USED TO ANALYZE THE ORIGIN AND MODE OF THE REPLICATED FILTER VENT LEAK. THE LEAK APPEARED TO SEEP THROUGH THE FILTER VENT MATERIAL FROM VARIOUS LOCATIONS. THE PROBABLE CAUSE OF THE OBSERVED FILTER VENT LEAK IS TEMPORARY OR PERMANENT LOSS OF THE HYDROPHOBIC PROPERTIES DUE TO INFUSATE INTERACTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8657584 ↗
• MalfunctionMay 31, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A PLUM SET WITH LEAKAGE ON THE FILTER. THIS RECORD CAPTURES THE FIRST OF TWO DEVICES. THE REPORTED FILTER LEAK WAS CONFIRMED BY INVESTIGATION. ONE (1) USED LIST PLUM SET WAS RECEIVED FOR INVESTIGATION. AS RECEIVED, THE RETURNED SET WAS VISUALLY INSPECTED AND THE FILTER VENT WAS OBSERVED TO BE WETTED AND/OR SATURATED. THE REPORTED INFUSATE WAS TAXOL. THE RETURNED SET WAS LEAK TESTED PER THE PRODUCT SPECIFICATIONS AND A LEAK WAS OBSERVED FROM THE FILTER VENT OF THE FILTER OF THE RETURNED SETS. RED DYED WATER WAS USED TO ANALYZE THE ORIGIN AND MODE OF THE REPLICATED FILTER VENT LEAK. THE LEAK APPEARED TO SEEP THROUGH THE FILTER VENT MATERIAL FROM VARIOUS LOCATIONS. THE PROBABLE CAUSE OF THE OBSERVED FILTER VENT LEAK IS TEMPORARY OR PERMANENT LOSS OF THE HYDROPHOBIC PROPERTIES DUE TO INFUSATE INTERACTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8657582 ↗
• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PLUMSET THAT THE CUSTOMER REPORTED HAD LEAKAGE ON THE CONNECTING SIDE OF THE FILTER AND THE TUBE DURING PRIMING OF TAXOL. THERE WAS NO OBVIOUS DEFECTS NOTED ON THE TUBING. THE TUBING WAS REPLACED AND THERAPY RESUMED. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8286613 ↗
• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A PLUMSET THAT THE CUSTOMER REPORTED HAD LEAKAGE ON THE CONNECTING SIDE OF THE FILTER AND THE TUBE DURING PRIMING OF TAXOL. THERE WAS NO OBVIOUS DEFECTS NOTED ON THE TUBING. THE TUBING WAS REPLACED AND THERAPY RESUMED. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8286596 ↗