SmartPump 5920011000Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 07613154589647), received between Jun 14, 2018 and Apr 22, 2026 — classified as 1 injury, 71 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (49 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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Decrease in Pressure

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 0 EVENTS FOR THE FAILURE: DECREASE IN PRESSURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954388 ↗
• MalfunctionJan 23, 2026Decrease in Pressure

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 16 EVENTS FOR THE FAILURE: DECREASE IN PRESSURE. - 6 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 3 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD INSUFFICIENT INFORMATION. - 1 EVENT HAD MINOR INJURY/ILLNESS/IMPAIRMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163096 ↗
• MalfunctionOct 28, 2025Decrease in Pressure; Decrease in Pressure

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025 ¿ (B)(6) 2025. THIS REPORT SUMMARIZES 11 EVENTS FOR THE FAILURE: DECREASE IN PRESSURE. - 9 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399775 ↗
• MalfunctionOct 23, 2025Increase in Pressure; Increase in Pressure

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369356 ↗
• MalfunctionJul 29, 2025Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 11 EVENTS FOR THE FAILURE: DECREASE IN PRESSURE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 8 EVENTS HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647052 ↗
• MalfunctionJul 29, 2025Decrease in Pressure; Increase in Pressure; Decrease in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURES: DECREASE IN PRESSURE; INCREASE IN PRESSURE. 1 EVENT HAD INSUFFICIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647006 ↗
• MalfunctionApr 21, 2025Decrease in Pressure; Increase in Pressure; Decrease in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE AND THEN AN INCREASE IN PRESSURE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876279 ↗
• MalfunctionFeb 20, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE DOES NOT HOLD PRESSURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 21420622 ↗
• MalfunctionJan 22, 2025Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 24 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 3 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 16 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207550 ↗
• MalfunctionJan 22, 2025Increase in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCREASE IN PRESSURE. - 3 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207493 ↗
• MalfunctionOct 21, 2024Increase in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCREASE IN PRESSURE. - 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498532 ↗
• MalfunctionOct 21, 2024Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 19 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 10 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 5 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT. 4 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498498 ↗
• MalfunctionOct 21, 2024Decrease in Pressure; Increase in Pressure; Decrease in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A PRESSURE IRREGULARITY. 3 EVENTS WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.

  Patient problems: Bruise/Contusion

  MAUDE report 20493932 ↗
• InjurySep 9, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT AFTER REMOVING THE TOURNIQUET IN THE OPERATING ROOM, IT WAS NOTED THAT THE PATIENT'S SKIN WAS WARM, DRY, AND BLANCHABLE. WHEN THE SKIN ASSESSMENT WAS COMPLETED IN THE POST ANESTHESIA CARE UNIT, THE REGISTERED NURSE INSPECTED THE RIGHT LOWER EXTREMITY AND NOTED THAT THE PATIENT HAD CIRCUMFERENTIAL SWELLING IN THE RIGHT THIGH AT THE TOURNIQUET SITE WITH REDNESS AND BLANCHABLE. IT WAS FURTHER REPORTED THAT THE PATIENT SUFFERED ERYTHEMA AND SWELLING/ EDEMA AS WELL AS DEVELOPING COMPARTMENT SYNDROME, WHICH REQUIRED A FASCIOTOMY. THERE WAS NO DELAY IN THE PROCEDURE AS THE DEVICE WAS USED IN THE PRIMARY CASE, AND THE COMPLICATION OF THE COMPARTMENT SYNDROME WAS DIAGNOSED POST-OPERATIVELY. APPROPRIATE INTERVENTIONS WERE PERFORMED WITHOUT DELAY.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20175793 ↗
• MalfunctionJul 24, 2024Decrease in Pressure; Increase in Pressure; Decrease in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE AND THEN AN INCREASE IN PRESSURE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823246 ↗
• MalfunctionJul 24, 2024Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 32 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. - 18 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 11 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 3 EVENTS HAD INSUFFICIENT INFORMATION REGARDING HEALTH IMPACT RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823144 ↗
• MalfunctionJul 24, 2024Increase in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD AN INCREASE IN PRESSURE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818513 ↗
• MalfunctionApr 17, 2024Decrease in Pressure; Increase in Pressure; Decrease in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE DEVICE IS ALARMING WHEN INFLATED PAST NINETY; THE PRESSURE THEN BEGINS TO SWING WILDLY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING CLEANING AT THE END USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19129005 ↗
• MalfunctionJan 22, 2024Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 30 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 20 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 10 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557608 ↗
• MalfunctionJan 22, 2024Increase in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD AN INCREASE IN PRESSURE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18555913 ↗
• MalfunctionOct 23, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 31 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 24 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993144 ↗
• MalfunctionOct 23, 2023Decrease in Pressure; Increase in Pressure; Decrease in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE AND THEN AN INCREASE IN PRESSURE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990689 ↗
• MalfunctionJul 26, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 44 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. - 34 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 9 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401587 ↗
• MalfunctionJul 26, 2023Increase in Pressure; Increase in Pressure

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCREASE IN PRESSURE. - 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397014 ↗
• MalfunctionApr 25, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 16 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 14 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807849 ↗