SMARTeZ Pump 484011Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18859299104017), received between Feb 19, 2019 and Mar 6, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 6, 2020Microbial Contamination of Device

  ON 05/22 - PT CONNECTED TO DISPOSABLE INFUSION DEVICE (SMART Z) FOR 46 HRS. INFUSION OF FLUOROURACIL. PT RETURNED TO INFUSION SUITE AM 05/23 AFTER NOTING VISIBLE BLOOD IN TUBING FROM PORT NEEDLE SITE TO INFUSION PUMP. WRAPPING HAD BEEN APPLIED TO SITE OF NEEDLE/PUMP CONNECTION AT TIME PLACED 05/22 TO INSURE TIGHT CONNECTION. AT TIME OF ARRIVAL TO CHO, TAPE NOTED WET WITH 5FU RESIDUE PRESENT ON PT'S UPPER ABDOMEN. ALL CLAMPS EXAMINED AND WERE OPEN. PHYSICIAN NOTIFIED, PHARMACY RECALIBRATED DOSE FOR 24 HR 5FU INFUSION. PT DISCHARGED TO HOME WITH INFUSION VIA CADD PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9801645 ↗
• MalfunctionMar 6, 2020Break; Fluid/Blood Leak

  PT HAD A 46 HOUR AMBULATORY "SMART" PUMP WITH FLUOROURACIL INFUSION. ATTACHED ON (B)(6) 2019 VIA RIGHT CHEST PORT. PT CALLED IN THE MORNING ON (B)(6) STATING THAT THE PUMP WAS LEAKING. PT PRESENTED TO OFFICE THIS MORNING WITH MALFUNCTION CHEMO"SMART" PUMP. HUPPPER NEEDLE WAS SECURE AND IN PLACE WITH STERILE DRESSING AND BIOPATH BUT TUBING FROM HUMMER NEEDLE TO BLUE CLAVE ADAPTOR WAS FULL OF BLOOD. CONNECTION SITE FROM CLAVE TO SMART PUMP TUBING WAS SECURED WITH TAPE BUT WAS LEAKING BLOOD AND 5FU CHEMOTHERAPY. PT HAD DRIED 5FU (IN THE FORM OF POWDER) ON HER ABDOMEN AND FANNY PACK. ALL CLAMPS WERE OPEN. CLAMPS WERE THEN CLOSED AND PUMP DISCONNECTED FROM BLUE CLAVE ADAPTOR. IT WAS THEN NOTED THAT THE MALE ADAPTOR FROM THE SMARTPUMP TUBING WAS BROKEN OFF INSIDE THE CLAVE ADAPTOR. PORT ACCESS WAS REMOVED WITHOUT FLUSHING AND ALL LINES AND PUMP WERE SECURED IN BIOHAZARD BAG. PT'S SKIN AND SURROUNDING AREA WAS WASHED WITH NS AND GAUZE. PORT WAS RE-ACCESSED UNDER STERILE TECHNIQUE, FLUSHED WITHOUT RESISTANCE AND HAS A GOOD BLOOD RETURN. MD NOTIFIED OF INCIDENT. PT IS REFUSING A NEW PUMP AT THIS TIME. PT REPORTED SIDE EFFECTS OF BLURRED VISION STARTING YESTERDAY EVENING - TO THE PINT THAT S

  Patient problems: Chemical Exposure; Visual Impairment

  MAUDE report 9801643 ↗
• MalfunctionFeb 19, 2019Leak/Splash

  A (B)(6) MALE WITH A HISTORY OF CANCER WAS SEEN IN THE CHEMOTHERAPY INFUSION CENTER FOR TREATMENT. THE PT WAS STARTED ON 5FU VIA A SMART EZ PUMP FOR HOME INFUSION. THE NEXT MORNING THE PT CALLED THE CHEMOTHERAPY INFUSION CENTER , AND STATED. "SOMETHING IS WRONG WITH THE PUMP." THE PT WAS INSTRUCTED TO COME TO THE CHEMOTHERAPY INFUSION CENTER RIGHT AWAY. WHEN THE PT ARRIVED, THE PUMP WAS LEAKING ON HIS BODY. THE PT CLEANED. THE LEAK WAS NOTED TO BE AT THE CONNECTION BETWEEN SMARTEZ PUMP AND POSIFLOW. THE MALE PIECE OF THE LUER LOCK END OF THE SMARTEZ PUMP WAS FOUND TO BE BROKEN OFF AND LODGED IN THE POSIFLOW. PICTURES WERE TAKEN AND THE MFR REP WAS NOTIFIED.

  Patient problems: Chemical Exposure

  MAUDE report 8350444 ↗
• MalfunctionFeb 19, 2019Break; Crack; Leak/Splash

  A (B)(6) FEMALE WITH A HISTORY OF CANCER WAS SEEN IN THE CHEMOTHERAPY INFUSION CENTER FOR TREATMENT. THE PT WAS STARTED ON 5FU VIA A SMART EZ PUMP FOR HOME INFUSION . THE PT CALLED THE NEXT MORNING BECAUSE SHE NOTICED THE 5FU SMART EZPUMP WAS LEAKING. SHE WAS TOLD TO COME TO THE CHEMOTHERAPY INFUSION CENTER RIGHT AWAY. UPON EXAMINATION, A CRACK WAS NOTED AT THE CONNECTION BETWEEN SMARTEZ PUMP AND POSIFLOW. ADDITIONALLY, THE MALE PIECE OF THE LUERLOCK WAS BROKEN OFF AND LODGED INTO POSIFLOW. PHOTOGRAPHS WERE TAKEN. THE MFR REP WAS NOTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350381 ↗