DOSI-FUSER L25915-150D2-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08436020760068), received between Oct 23, 2017 and May 28, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE DRUG PRODUCT HAS PRECIPITATED AND DAMAGED THE CAPILLARY ELEMENT OF THE DOSI-FUSER. THE DAMAGE CAUSED MORE DRUG TO LEAK FROM THE CAPILLARY ELEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547425 ↗
• MalfunctionJan 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  LEAK AT CAPILLARY ELEMENT. PATIENT HAD CHEMOTHERAPY (FLUOROURACIL) IN A DOSI-FUSER AMBULATORY PUMP, AND WHEN SHE CAME IN TO HAVE PUMP DISCONNECTED IT WAS NOTICED THAT THE FLUOROURACIL HAD LEAKED THROUGH THE CAPILLARY MECHANISM OF THE PUMP. IT WAS UNKNOWN HOW MUCH DOSE PATIENT RECEIVED AND HOW MUCH LEAKED OUT FOR THE PRIOR TWO DAYS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7178510 ↗
• MalfunctionNov 23, 2017Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT PRESENTED FOR 5-FU INFUSER PUMP DISCONNECTION. PATIENT REPORTED HE NOTICED THE PUMP WAS LEAKING SHORTLY BEFORE PRESENTING FOR THE APPOINTMENT. UPON INSPECTION, THE PUMP AND MEDICATION CARRIER DID HAVE WHITE RESIDUE AND THE PUMP APPEARED EMPTY. THE PATIENT WAS EXPOSED TO CHEMO VIA THE SKIN AND CLOTHING. NO ADVERSE EVENTS HAVE BEEN REPORTED BY THE PATIENT DUE TO EXPOSURE. THE LEAKING APPEARS TO HAVE OCCURED WHERE THE DRUG IS ADDED TO THE INFUSER. THE MANUFACTURER IS SENDING A RETURN PACKAGE TO DO A FULL EVALUATION OF THE PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7057132 ↗
• MalfunctionOct 27, 2017Detachment Of Device Component; Device Dislodged or Dislocated; Manufacturing, Packaging or Shipping Problem; Detachment Of Device Component; Device Dislodged or Dislocated; Manufacturing, Packaging or Shipping Problem

  DEFECTIVE DOSI-FUSER 150D2 PUMP. PRIOR TO FILLING THE PUMP, TECHNICIAN NOTED THAT "LEVEL INDICATOR" HAS DISLODGED FROM THE TOP OF THE BALLOON AND WAS FLOATING FREELY WITHIN THE CONTAINER. THIS COULD POSE A PROBLEM IN DETERMINING IF A PATIENT'S INFUSION HAS COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 6982750 ↗
• InjuryOct 23, 2017Excess Flow or Over-Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Infusion or Flow Problem

  PATIENT IS BEING TREATED FOR COLON CANCER. REPORTING (B)(6) FOR FOLFOX ADJUNCT CHEMO AND FOR ATTACHMENT OF HIS 5-FU PUMP WHICH SHOULD INFUSE OVER ABOUT 48 HOURS. THE PATIENT CALLED EARLY IN THE MORNING OF (B)(6), STATING HIS PUMP WAS EMPTY AND HAD BEEN EMPTY SINCE ABOUT 6:30 THE EVENING BEFORE. THE PATIENT WAS ASKED TO COME IN AND WAS ADMITTED FOR POSSIBLE 5-FU TOXICITY. HE IS DOING VERY WELL AND IS GETTING THE ANTIDOTE AS AN INPATIENT. THIS WAS A CONSERVATIVE MEASURE SINCE THE PATIENT WAS ON THE BORDERLINE FOR SAFE ADMINISTRATION OF THE DRUG. THE PATIENT WAS USING A DOSI-FUSER PUMP WHICH WORKS BY PRESSURE AND VISCOSITY.

  Patient problems: Injury; Toxicity

  MAUDE report 6967923 ↗