DOSI-FUSER L25915-100D2-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08436020763861), received between May 24, 2018 and May 28, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2018Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  PATIENT STARTED 5-FU CONTINUOUS INFUSION AS PART OF FOLFOX CHEMOTHERAPY REGIMEN TO BE DELIVERED VIA DOSI-FUSER. (TOTAL VOLUME 86.3 ML; 100 ML/2 DAY/1.9 ML PER HOUR). PATIENT OBSERVED IN ONCOLOGY CLINIC WITH MALFUNCTIONED PUMP. LNNER BALLOON HAD BURST AT SOME POINT (PATIENT NOT ABLE TO DETERMINE WHEN) AND DRUG MOVING FREELY THROUGH CHAMBER, DRUG NOT DELIVERED TO PATIENT. NDC: 100 ML 2 DAY PUMP 1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547869 ↗
• MalfunctionMay 24, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PATIENT'S CHEMOTHERAPY ORDERED FOR 3750 MG TO INFUSE OVER 46 HOURS USING A DOSI-FUSER 100 AT 1.9 ML/HR. PATIENT WAS SEEN TO HAVE INFUSER DISCONTINUED AND IT WAS NOTED IT HAD NOT INFUSED COMPLETELY. THE PATIENT'S PORT WAS FLUSHED WITHOUT DIFFICULTY AND THE INFUSER WAS RECONNECTED. THE PATIENT RETURNED THE NEXT DAY AND THE INFUSER WAS RECONNECTED. THE PATIENT RETURNED THE NEXT DAY AND THE INFUSER REMAINED HALF FULL. THE PORT WAS FLUSHED AGAIN WITHOUT DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540766 ↗
• MalfunctionMay 24, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PATIENT'S DOSI-FUSER (100 ML AT 1.9ML/HR FOR 46 HOURS) DID NOT DELIVER PATIENT CHEMOTHERAPY PROPERTY. PER PHARMACIST THE PATIENT ONLY RECEIVED HALF OF THE INTENDED DOSE. PATIENT'S PORT LOCATED IN THE RIGHT UPPER CHEST FLUSHED WITH NORMAL SALINE WITHOUT DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540280 ↗
• MalfunctionMay 24, 2018Partial Blockage; Loss of or Failure to Bond; Failure to Infuse; Partial Blockage; Loss of or Failure to Bond; Failure to Infuse

  PATIENT PRESENTED TO CLINIC BECAUSE HER PUMP WAS NO LONGER INFUSING MEDICATION. LABEL INDICATING VOLUME AND INFUSION RATE PROVIDED BY THE MANUFACTURER INSIDE THE PUMP CAPSULE WAS BENT AND WAS IMPEDING THE LEVEL INDICATOR. CONTACTED THE MFR AND THEY INDICATED THAT THE PUMPS WERE RECENTLY UPGRADED PUTTING SO THAT THE LABELS WERE NOW INSIDE RATHER THAN OUTSIDE THE PUMP. PUMP HAD TO BE DISCONNECTED AND MEDICATION HAD TO BE PUT IN A 24 HOUR PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7539912 ↗