SMARTeZ Pump 481062Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 28859299101068), received between Nov 15, 2018 and Feb 19, 2019 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• 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 ↗
• 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 8350394 ↗
• 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 8350393 ↗
• MalfunctionFeb 19, 2019Failure to Infuse

  SMARTEZ PUMP ((B)(4), LOT# S8H02) TELAVANCIN 750 MG IN 0.9% SODIUM CHLORIDE 250ML TOOK 4 HOURS TO INFUSE. PATIENT LINE FLUSHING WITHOUT PROBLEMS. ED DRIPS QUICKLY WHEN DISCONNECTED AND UNCLAMPED. RECONNECTED ED TIGHTLY WITHOUT IMPROVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350386 ↗
• MalfunctionJan 23, 2019Leak/Splash

  PHARMACY TECHNICIAN ATTEMPTED TOFILL A SMARTEZ PUMP (SE0L75-250, LOT# S8H02) WITH 0.9% SODIUM CHLORIDE WHEN FLUID BEGAN SPRAYING OUT AT THE FILL PORT SEAL AREA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8272152 ↗
• MalfunctionDec 10, 2018Failure to Infuse

  SMARTEZ PUMP (SE0175-250. LOT# S8H02) CONTAINING TELEVANCIN 1300 MG IN 0.9% SODIUM CHLORIDE 250 ML WOULD NOT INFUSE. DOSE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8147453 ↗
• MalfunctionDec 10, 2018Infusion or Flow Problem

  SMARTEZ PUMP (MODEL SE0175-250, LOT# S8H02) CONTAINING VANCOMYCIN 1500 MG IN 0.9% SODIUM CHLORIDE 250 ML WOULD NOT INFUSE. THE PUMP SEEMS TO WORK FINE WHEN UNCLAMPED AND NOT ATTACHED TO LINE. PRS LINE WORKING FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8147449 ↗
• MalfunctionDec 10, 2018Leak/Splash

  TECH USING REPEATER PUMP TO FILL SMARTEZ PUMP ((B)(4), LOT# S8H02) WITH 0.9% SODIUM CHLORIDE AND FLUID BEGAN LEAKING OUT AT BASE OF ELASTOMERIC DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8147444 ↗
• MalfunctionNov 15, 2018Failure to Deliver

  TWO (2) SMARTEZ PUMPS (250 ML VOLUME; 175 MUHR) FILLED WITH VANCOMYCIN 1 G/0.9% SODIUM CHLORIDE WOULD NOT INFUSE. SMARTEZ PUMP LOT: S8H11. THERAPY START DATE: (B)(6) 2018. NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074954 ↗