SMARTeZ PumpRecalls & reported problems across all models

We found 5 models of SMARTeZ Pump by Epic International(Thailand) Company Limited in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Mar 6, 2020 — classified as 2 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SMARTeZ Pump problems

SMARTeZ Pump models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SMARTeZ Pump 481012

  Pump, Infusion, Elastomeric
  26 reports
• SMARTeZ Pump 481062

  Pump, Infusion, Elastomeric
  12 reports
• SMARTeZ Pump 484011

  Pump, Infusion, Elastomeric
  4 reports
• SMARTeZ Pump 484041

  Pump, Infusion, Elastomeric
  2 reports
• SMARTeZ Pump 480041

  Pump, Infusion, Elastomeric
  1 report

Recent SMARTeZ Pump adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 6, 2020Excess Flow or Over-Infusion

  PATIENT REPORTED THAT SMARTEZ PUMP THAT SHOULD HAVE INFUSED OVER 24 HR COMPLETED IN ABOUT 12 HRS. MEDICATION DISPENSED IN THE 10ML/HR, 270ML FILL SMARTEZ PUMP. THE FACILITY RETRIEVED SEVEN PUMPS FROM THE PATIENT. ONE RAN FAST, THE REMAINING WERE RETRIEVED FOR QA. SEVEN DEVICES AVAILABLE FOR EVALUATION. (ALTHOUGH AWARENESS DATE WAS 1/11, COMPLETE INFORMATION WAS NOT AVAILABLE TIL 1/24).

  Patient problems: Overdose

  MAUDE report 9801646 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 19, 2019Leak/Splash

  SMARTEZ PUMP (SE0200 -100, LOT# S8E46) CONTAINING ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML LEAKING AT FILTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350459 ↗
• MalfunctionFeb 19, 2019Infusion or Flow Problem

  SLOW FLOW WITH VANCOMYCIN 2 G/NS 250 ML SMARTEZ {SE0175-250; LOT· S8H02} AND CEFTRIAXONE 2 G/NS 100ML SMARTEZ {SE0200-100; LOT S8D33): 100 ML, 200ML /HR AND SMARTEZ 250 ML, 175 ML/HR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350454 ↗
• MalfunctionFeb 19, 2019Failure to Infuse

  SMARTEZ PUMP (SE0200-100, LOT# S8E46) CONTAINING DAPTOMYCIN350 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. LINE FLUSHING WITHOUT PROBLEM. RN DISCONNECTED/ REFLUSHED / RECONNECTED AND THEN IT EVENTUALLY INFUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350448 ↗
• MalfunctionFeb 19, 2019Improper Flow or Infusion

  SMARTEZ PUMP (SE0175-250, LOT# S8H02) CONTAINING VANCOMYCIN 1 GRAM IN 0.9% SODIUM CHLORIDE 250 ML IS TAKING 2-3 HOURS TO INFUSE. LINE IS FLUSHING GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350446 ↗
• 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, 2019Fluid/Blood Leak; Failure to Infuse

  SMARTEZ PUMPS (SE0175-250 , LOT# S8H02 X3) CONTAINING VANCOMYCIN 1.5 GRAM IN 0.9% SODIUM CHLORIDE 250 ML; 1 WOULD NOT INFUSE, 1 WAS TAKING OVER 5 HOURS TO INFUSE (BOTH DRIPPED WHEN DISCONNECTED AND UNCLAMPED), AND 1 LEAKED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350437 ↗
• MalfunctionFeb 19, 2019Leak/Splash; Failure to Infuse

  SMARTEZ PUMPS (SE0175-250, LOT# S8H02 X3) CONTAINING VANCOMYCIN 1.5 GRAM IN 0.9% SODIUM CHLORIDE 250 ML; 1 WOULD NOT INFUSE, 1 WAS TAKING OVER 5 HOURS TO INFUSE (BOTH DRIPPED WHEN DISCONNECTED AND UNCLAMPED), AND 1 LEAKED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350436 ↗
• MalfunctionFeb 19, 2019Fluid/Blood Leak

  THREE (3) SMARTEZ PUMPS (SE0200-100, LOT# S7N32) BEGAN LEAKING AT THE BOTTOM SHOULDER WHERE THE BLADDER MEETS THE BOTTOM RING, WHEN THE TECH STARTED FILLING WITH 0.9% SODIUM CHLORIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350435 ↗
• MalfunctionFeb 19, 2019Leak/Splash

  THREE (3) SMARTEZ PUMPS (SE0200-100, LOT# S7N32) BEGAN LEAKING AT THE BOTTOM SHOULDER WHERE THE BLADDER MEETS THE BOTTOM RING, WHEN THE TECH STARTED FILLING WITH 0.9% SODIUM CHLORIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350433 ↗
• InjuryFeb 19, 2019Insufficient Flow or Under Infusion

  SLOW FLOW WITH VANCOMCYIN 2 G/NS 250 ML SMARTEZ {SEOL75-250; LOT: S8H02} AND CAFTRIAXONE 2 G/NS 100ML SMARTEZ {SE0200-100; LOT S8D33}. {SIX (6) DOSES OF VANCOMYCIN AND FOUR (4) DOSES OF CEFTRIAXONE HAD TO BE REPLACED); 100 ML, 200 ML /HR AND SMARTEZ 250 ML. 175 ML/HR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350429 ↗

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