Perfusor® 8713080URecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046963915308), received between Mar 18, 2021 and Jun 23, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 14, 2024Open, Classified

   Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.

   Z-2435-2024 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionJun 23, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: FENTANYL CONTINUOUS INFUSION SET UP AND CHECKED. PER BEDSIDE NURSE SHE HAD TO PAUSE THE INFUSION PUMP TO CHECK PRESSURES-PUMP PLACED IN STANDBY. NOTHING WAS MODIFIED UPON RESTARTING AND WITH 20 MINUTES THE SYRINGE HAD INFUSED. THE ORIGINAL INFUSION WAS AT .05CC AND WAS LATER FOUND INFUSING AT 25ML/HR.. IT WAS ORIGINALLY STARTED AS A CONTINUOUS SEDATION. GTB AND PLASTICS NOTIFIED. TREATMENT ORDERS GIVEN. PCA STOPPED. PUMP AND TUBING REMOVED.. PUMP TURNED IN TO MAINTENANCE. AFTER SPEAKING TO GTB THIS SIMILAR ISSUE WAS NOTED WIN @D WITH A PCA SYRINGE BEING INFUSED AS A BOLUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596938 ↗
• MalfunctionMay 4, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: POTENTIAL ISSUE WITH THE IV INFUSION PUMP/PROGRAMMING LEADING TO LIKELY MEDICATION ERROR RECOGNIZED AS FENTANYL SYRINGE SCANNED AND STARTED AT 1854, IMMEDIATELY PRIOR TO CHANGE OF SHIFT ALARMED WITH VTBI WARNING AND APPEARS EMPTY AT APPROX. 1945. GTB APP, CHARGE NURSE, AND PHARMACY NOTIFIED WITHOUT FURTHER INTERVENTIONS NEEDED AS PATIENT IS ALREADY INTUBATED AND MECHANICALLY VENTILATED. NO SIGNS OF COMPLICATIONS NOTED ASIDE FROM DECREASED RAAS. PROPOFOL DOSE CUT SIGNIFICANTLY TO ASSESS NEURO STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072227 ↗
• MalfunctionJan 15, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: PATIENT (CMO) GOT A NEW SYRINGE (15ML) FENTANYL INITIATED AT SHIFT CHANGE (1914). MED CONCENTRATION WAS 50MCG/1ML. RATE 75MCG PER HOUR. SYRINGE SHOULD HAVE BEEN EMPTY AT 0514 (10 HOURS). WHEN RN WENT IN AT 5AM TO CHANGE SYRINGE, THE MACHINE SAID VTBI WAS 0.76, WHICH WOULD MATCH UP WITH RATE/TIMING. HOWEVER, WHEN SYRINGE WAS CHANGED, THERE WAS STILL >5ML IN SYRINGE TO WASTE. WHEN SYRINGE WAS CHANGED AT SHIFT CHANGE, THERE WAS NO ISSUES.

  Patient problems: Irritability

  MAUDE report 24084147 ↗
• MalfunctionJun 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: WHEN PUMP DISCONTINUED THERE WAS 4 ML/4 MG MORPHINE LEFT IN SYRINGE AND PUMP SHOWED 22.8 ML/MG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206093 ↗
• MalfunctionMay 16, 2025Excess Flow or Over-Infusion; Data Problem; Excess Flow or Over-Infusion; Data Problem

  AS REPORTED BY THE USER FACILITY: PATIENT INTUBATED AND SEDATED WITH PROPOFOL AND 50MCG/HR OF FENTANYL. WHEN FENTANYL SYRINGE WAS DUE TO BE CHANGED THE PUMP SWITCHED TO A DIFFERENT MODE OF THE THERAPY AND INSTEAD WAS PROGRAMMED TO RUN AT 50 ML/HR. THE ENTIRETY OF THE 15 ML FENTANYL SYRINGE WAS INFUSED INTO THE PT. AT 50 ML/HR INSTEAD OF 50 MCG/HR. PUMP WAS REMOVED FROM ROOM AND TAGGED FOR SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039920 ↗
• MalfunctionJun 12, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: RN IN PACU SET PCA PUMP TO INFUSE 50ML PER MD'S ORDER. PATIENT THEN MOVED TO A NURSING FLOOR. WHEN RN WAS GIVING REPORT, SHE NOTICED THE 50MLS FIRST PROGRAMMED WAS NOW SET TO 0. PATIENT WAS STILL ABLE TO GET INTERMITTENT INFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106197 ↗
• MalfunctionMay 8, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: THE NURSE CLAIMED THE PCA PUMP INACCURACIES. SAID THAT PUMP ALERTED VIAL EMPTY BUT THERE WAS STILL 9ML'S LEFT IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885603 ↗
• MalfunctionMay 8, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: THE NURSE CLAIMED THE PCA PUMP INNACURACIES. SAID THAT PUMP ALARTED VIAL EMPTY BUT THERE WAS STILL 9ML'S LEFT IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885581 ↗
• MalfunctionMay 8, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: THE NURSE CLAIMED THE PCA PUMP INACCURACIES. SAID THAT PUMP ALERTED VIAL EMPTY BUT THERE WAS STILL 9ML'S LEFT IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885144 ↗
• MalfunctionMay 19, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: WHEN THE PATIENT WAS DISCHARGED, THE REMAINING VOLUME IN THE SYRINGE WAS 19ML, BUT THE PUMP INDICATED THAT THERE SHOULD BE 29.98ML REMAINING TO BE INFUSED. THE INFUSION WAS STARTED WITH A 50ML BD SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847558 ↗
• MalfunctionMay 19, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: THE INFUSION WAS STARTED WITH A 50ML BD SYRINGE, INFUSING MORPHINE. THE PUMP ALARMED THAT THE SYRINGE WAS EMPTY, BUT IT WAS READING THAT 34.64MLS WERE DELIVERED, WITH 15.36MLS REMAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847556 ↗
• MalfunctionMar 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY USER FACILITY: A PATIENT'S MEDICATION (MORPHINE) DOSING ON PCA PUMP SHOULD HAVE BEEN STEADY BUT NURSE NOTICED IT WAS CHANGED WITHOUT AUTHORIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515414 ↗