SMARTeZ Pump 484041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18859299104048), received between Aug 5, 2019 and Mar 6, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2020Inaccurate Flow Rate

  THE PATIENT WAS PUT ON AN ELASTOMERIC INFUSION PUMP ON 7/23 AT 1600 THAT WAS SET TO INFUSE 230ML OVER 46HRS RATE APPROX 5ML/HR. THE PATIENT CALLED THE CLINIC AT APPROXIMATELY 1000 ON 7/24 STATING THAT THE PUMP LOOKED SMALLER THAN NORMAL. THE PHARMACIST DIRECTED HER TO STOP THE PUMP FROM INFUSING. WHEN SHE RETURNED TO THE PHARMACY THE PUMP WAS DRAINED AND DETERMINED TO HAVE 48ML LEFT OUT OF THE 230ML IT WAS FILLED WITH. THE CALCULATIONS AND COMPOUNDING WERE VERIFIED TO BE CORRECT. BASED ON THE TIME AND VOLUME REMAINING THE PUMP THE RATE OF INFUSION WAS DETERMINED TO BE APPROXIMATELY 10ML/HR, DOUBLE THE STATED RATE. OVER THE COURSE OF 18 HOURS OF INFUSION THE PATIENT RECEIVED 3500MG OF FLUOROURACIL. THE ONCOLOGIST DECIDED IT WAS BEST TO TREAT THE PATIENT WITH VISTOGARD (URIDINE TRIACETATE) THE REVERSAL DRUG FOR FLUOROURACIL OVERDOSE. THE PATIENT RECEIVED THE DRUG IN THE 96 HOUR TIME FRAME AND HAS NOT REPORTED ANY ADDITIONAL SIDE EFFECTS. THE PHARMACY HAS CONTACTED THE PUMP MANUFACTURER ABOUT THE DEVICE ERROR. IN FOLLOW UP CONVERSATION WITH RAMIRO, PATIENT ACTIVITY DURING THIS TIME WAS NORMAL. PATIENT WAS NOT OUTSIDE OR INVOLVED IN ACTIVITY THAT WOULD EXPOSE TO HIGH LEVELS OF HEAT. PA

  Patient problems: Overdose; Test Result

  MAUDE report 9801648 ↗
• InjuryAug 5, 2019Excess Flow or Over-Infusion

  THE PATIENT WAS PUT ON AN ELASTOMERIC INFUSION PUMP ON 07/23 AT 1600 THAT WAS SET TO INFUSE 230ML OVER 46HRS RATE APPROX 5ML/HR. THE PATIENT CALLED THE CLINIC AT APPROXIMATELY 1000 ON (B)(6) STATING THAT THE PUMP LOOKED SMALLER THAN NORMAL. THE PHARMACIST DIRECTED HER TO STOP THE PUMP FROM INFUSING. WHEN SHE RETURNED TO THE PHARMACY THE PUMP WAS DRAINED AND DETERMINED TO HAVE 48ML LEFT OUT OF THE 230ML IT WAS FILLED WITH. THE CALCULATIONS AND COMPOUNDING WERE VERIFIED TO BE CORRECT. BASED ON THE TIME AND VOLUME REMAINING THE PUMP THE RATE OF INFUSION WAS DETERMINED TO BE APPROXIMATELY 10ML/HR, DOUBLE THE STATED RATE. OVER THE COURSE OF 18 HOURS OF INFUSION THE PATIENT RECEIVED 3500MG OF FLUOROURACIL. THE ONCOLOGIST DECIDED IT WAS BEST TO TREAT THE PATIENT WITH VISTOGARD (URIDINE TRIACETATE) THE REVERSAL DRUG FOR FLUOROURACIL OVERDOSE. THE PATIENT RECEIVED THE DRUG IN THE 96 HOUR TIME FRAME AND HAS NOT REPORTED ANY ADDITIONAL SIDE EFFECTS. THE PHARMACY HAS CONTACTED THE PUMP MANUFACTURER ABOUT THE DEVICE ERROR. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Overdose

  MAUDE report 8865855 ↗