Perfusor® 8713030URecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 04046963716745), received between Dec 13, 2016 and Sep 30, 2026 — classified as 3 deaths, 1 injury, 72 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (33 reports).

2 FDA recall records 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-2433-2024 · Root cause: Device Design · FDA record ↗

2. Feb 7, 2022Terminated

   Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.

   Z-0819-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Flow or Under Infusion

  As reported by the user facility:Intended infusion was 10 mL, actual was ~ 6.5 mL; pump documented a total of 10 mL was infused.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947797 ↗
• MalfunctionJul 14, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25811259 ↗
• MalfunctionMar 17, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: SPACE PERFUSOR PUMP DID NOT DELIVER EXPECTED VOLUME WITHIN EXPECTED INFUSION TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620537 ↗
• MalfunctionNov 14, 2025Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: NURSING STAFF SAID SOMETHING WENT WRONG CAUSING THE PUMP TO SWITCH FROM THE CORRECT SELECTION OF 20ML BD SYRINGE TO 30ML BD SYRINGE, CAUSING THE INCORRECT DOSAGE TO BE DELIVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555580 ↗
• MalfunctionAug 27, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: PUMP SENSES "SYRINGE NEARLY EMPTY" IT STARTS A 3 MINUTE COUNTDOWN TIMER AND INFUSION STOPS AFTER 3 MINUTES WHETHER THE SYRINGE IS ACTUALLY EMPTY OR NOT. THEN THE PUMP NEEDS TO BE RESTARTED AND THEN IT FINISHES THE REMAINDER OF THE INFUSION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902911 ↗
• MalfunctionMar 18, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE CUSTOMER: "ON (B)(6) 2025, AT ABOUT 2032HRS, RN NOTED THAT THE FENTANYL WAS RUNNING AT 50MCG/HR (1ML/HR) INSTEAD OF 15MCG/HR (0.3ML/HR). FENTANYL WAS TOPPED UP AT 0015HRS." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634867 ↗
• MalfunctionFeb 12, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: THE PUMP ADMINISTERED A LARGE DOSE OF MORPHINE IN A VERY SHORT TIME. PROGRAMMED TO ADMINISTER 30 MILLIGRAMS (MG) OF MORPHINE OVER 24 HOURS IN A VOLUME OF 24 MILLILITERS (ML), AT A SPEED OF 1 MILLILITER AN HOUR (ML/H), IT ADMINISTERED 13 MILLILITERS (ML) IN 1 HOUR 30 MINUTES, OR 16.25 MILLIGRAMS (MG) OF MORPHINE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363188 ↗
• MalfunctionFeb 11, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: A NURSE PREPARED AN OPS WITH POTASSIUM AND CONFIRMED THAT DURING THE PROCEDURE, IT WAS REPORTED THAT THE SYRINGE INFUSED 20 ML OF POTASSIUM WHILE "APPROACHING." AS A RESULT, THE PATIENT REQUIRED RESUSCITATION. DURING THE NEXT SHIFT, THE PATIENT WAS RESUSCITATED AGAIN DUE TO RESPIRATORY ACIDOSIS. INVASIVE VENTILATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER FACILITY: "REGARDING THE PATIENT, I REGRET TO INFORM YOU THAT THE PATIENT HAS PASSED AWAY. ACCORDING TO THE DEPARTMENT, THIS HAS NOTHING TO DO WITH THE INCIDENT INVOLVING THE PERFUSOR."

  Patient problems: Asystole

  MAUDE report 21354305 ↗
• MalfunctionJan 10, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE CUSTOMER: "PUMO WAS STARTED AT 1342 HR. WHEN STAFF WAS ADMINISTERING THE DRUG TO PATIENT, SHE SAID THAT THE BI-DIRECTIONAL LINK/ROVER WAS NOT WORKING AND WAS PROMPTED TO PROGRAM MANUALLY. INSTEAD OF ADMINISTERING 30 MCG/HR (INTENDED DOSE), STAFF MANUALLY PRESSED IN 300 MCG/HR. BY 1500HR, STAFF FOUND THAT 44ML WAS ALREADY INFUSED AND 6ML WAS LEFT." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124357 ↗
• DeathJan 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE CUSTOMER: THERE WAS AN UNDERDOSE - PATIENT DEATH. THE CUSTOMER HAS STATED THEY DO NOT BELIEVE THE PUMP IS AT FAULT, THEY WANT THE DATA HISTORY OF THE PUMP.

  Patient problems: Insufficient Information

  MAUDE report 21123852 ↗
• MalfunctionDec 18, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: VOLUME REFLECTED SHOULD BE 820 MICROGRAMS (MCG) IN TOTAL, BUT SHOWN AS 796.4 MICROGRAMS (MCG) IN TOTAL. VOLUME REFLECTED SHOULD BE IN WHOLE NUMBER AND NOT IN DECIMAL POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20967992 ↗
• MalfunctionNov 27, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: A PATIENT WAS BEING SEDATED FOR WORK UP AND THE SEDATION INVOLVED USING A PROPOFOL CRI. THE CRI WAS CONNECTED TO THE PATIENT AND PROGRAMMED TO GIVE A 2MG/KG BOLUS DOSE. HOWEVER, THE DOSE THE PATIENT RECEIVED WAS NEARLY A 10X OVERDOSE. AS FAR THE ANESTHETIST IN CHARGE OF THE CASE CAN SEE, THE PATIENT DETAILS, WEIGHT 11 KILOGRAMS (KG) , INFUSION RATE 0.1 MILLIGRAMS PER KILOGRAMS PER MINUTE (MG/KG/MINUTE) AND CONCENTRATION 10 MILLIGRAMS PER MILLILITER (MG/ML) WERE ALL PROGRAMMED CORRECTLY. WE ARE UNSURE IF THE BOLUS WAS ACCIDENTALLY PROGRAMMED TO DELIVER 20 MILLIGRAMS PER KILOGRAMS (MG/KG) INSTEAD OF 2 MILLIGRAMS PER KILOGRAMS (MG/KG) OR IF THE SYRINGE DRIVER GENUINELY MALFUNCTIONED.

  Patient problems: Cardiac Arrest

  MAUDE report 20792602 ↗
• MalfunctionNov 18, 2024Improper Flow or Infusion; Improper Flow or Infusion

  ACCORDING TO THE EVENT DESCRIPTION: ACCORDING TO OUR OBSERVATIONS, THE SENT-IN PUMP IS NOT DISPENSING CORRECTLY. DESPITE THE SET TIME OF 24 HOURS, IT ALWAYS FINISHES THE INFUSION EARLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706464 ↗
• MalfunctionOct 31, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE CUSTOMER: "INFUSOMAT SPACE PUMP (ASSET NO: 35934) ALARMED INFUSION COMPLETE. BLOOD TRANSFUSION COMMENCED AT 14.12HRS. STAFF NURSE HAD PROGRAMMED 276MLS OVER 4HRS INTO THE INFUSOMAT SPACE PUMP. BLOOD TRANSFUSION WAS RUNNING AT 69MLS/HR. INFUSION COMPLETE ON PUMP BUT NOTED ?APPROXIMATELY HALF OF THE BLOOD STILL IN THE BAG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576608 ↗
• MalfunctionOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: A PATIENT UNDERGING INFUSION THERAPY OF FANTANYL WAS OVER INFUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415765 ↗
• MalfunctionOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: A PATIENT UNDERGOING INFUSION THERAPY OF FENTANYL WAS OVER INFUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415762 ↗
• MalfunctionOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: SYRINGE OF FENTANYL 500MCG/10ML PLACED ON 2.9 AT 3:30 P.M. PROGRAMMED FLOW RATE: 20 MCG/H. ON 3.9 AT 8 A.M., EMPTY SYRINGE. ESTIMATED DURATION WAS 25 HOURS (WITHOUT BOLUS). MME RECEIVED ONLY 1 BOLUS OF 0.4 ML AT 7 P.M. ACCORDING TO THE ICLS + ICUS, PREPARATION OF THE PRODUCT COMPLIES WITH THE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415751 ↗
• MalfunctionOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: SYRINGE OF FENTANYL 500MCG/10ML PLACED ON 2.9 AT 6PM. PROGRAMMED FLOW RATE: 20 MCG/H. ON 3.9 AT 8AM, EMPTY SYRINGE. ESTIMATED DURATION WAS 25 HOURS (WITHOUT BOLUS). MR DID NOT RECEIVE A BOLUS DURING THE ENTIRE TREATMENT. ACCORDING TO THE ICLS + ICUS, PREPARATION OF THE PRODUCT COMPLIES WITH THE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415720 ↗
• MalfunctionJun 7, 2024Excess Flow or Over-Infusion; Noise, Audible; Excess Flow or Over-Infusion; Noise, Audible

  AS REPORTED BY THE USER FACILITY: IT WAS SAID THE UNIT HAD A LOUD MOTOR NOISE AND IT DELIVERED THE WRONG DOSE ON A PATIENT. ACCORDING TO THE CUSTOMER'S AIRMED TEAM IT ONLY DELIVERED HALF A DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490401 ↗
• MalfunctionJun 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: MEDICATION INFUSING WAS REMIFENTANIL ON A BBRAUN PUMP. PATIENT'S WEIGHT WAS 101 KILOGRAMS AND MEDICATION WAS PROGRAMMED AT 2MG IN 50ML. PER REPORTED THE PUMP WAS PROGRAMMED INCORRECTLY BUT THE GUARDRAIL DID NOT ALARM NOR STOPPED THE INFUSION. THE INFUSION SHOULD HAVE BEEN IN 1MG IN 20ML OR 2MG/40ML NOT 50ML. NO PATIENT INJURY REPORTED. THE REPORTER DOES NOT HAVE ANY INFORMATION THAT WOULD CONCLUDE THAT THE PATIENT WAS HARMED BUT WILL FOLLOW UP. THE REPORTER FEELS THAT IT MAY BEEN USER ERROR BUT CANNOT SAY FOR CERTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483117 ↗
• MalfunctionMay 16, 2024Improper Flow or Infusion; Improper Flow or Infusion

  ACCORDING TO THE CUSTOMER IT WAS REPORTED THAT THE PUMP WAS INFUSING INCORRECTLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335236 ↗
• MalfunctionFeb 15, 2023Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRAUN SYRINGE PUMP LOADED, SYRINGE PUMP FAILED TO RECOGNIZE SYRINGE AND DELIVERED ENTIRE VOLUME. SYRINGE WAS NOT CONNECTED TO PATIENT. NO INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381006 ↗
• MalfunctionDec 12, 2022Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PUMP HAD DELAY IN STOPPING FOR AN OCCLUSION AT LOW FLOW RATE. CONNECTED TO TRIFUSE WITH CARESITE. FLUID BACKED UP INTO SYRINGE. IV LINE WAS CONNECTED TO A TRIFUSE THAT HAD A CARESITE CONNECTED INSTEAD OF NEXUS TKO LOW FLOW RATE WAS 0.5 FOR THE CARRIER FLUID AND THERE WAS ALSO A MED LINE GOING AT .04ML/HR. PRESSURE SETTING DEFAULT 6, RN UNSURE IF IT HAD BEEN ADJUSTED. THE PUMP HAD A DELAY TO ALARM OCCLUSION EVEN FOR THE TWO HOURS THAT THE LINE WAS CLAMPED. THERE WERE NO ISSUES WITH MEDICATION ADMINISTERING WHEN AT HIGHER RATES. RN NOTICED 2ML BACKED UP INTO THE SYRINGE FROM PRECEDEX THAT WAS GOING AT 0.04ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958027 ↗
• MalfunctionDec 8, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: "THE RESPIRATORY THERAPIST STATED THAT THEY STARTED A CONTINUOUS NEBULIZER TREATMENT ON A PICU PATIENT FOR LBUTEROL 40MG OVER 4 HOURS AND THE INFUSION COMPLETED IN 1 HOUR. THEY DID NOT STATE THAT THERE WAS ANY PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942129 ↗
• MalfunctionDec 6, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: CUSTOMER STATES THAT THE ANESTHESIOLOGIST SET UP THE PUMP USING THE DRUG LIBRARY, SHE CHOSE PROPOFOL. 10MG/30ML, ENTERED THE PATIENT WEIGHT OF 61KG AND PRESSED START. A FEW MINUTES LATER THE PUMP ALARMED, AND SHE NOTED THAT THE SYRINGE WAS EMPTY AND THE ENTIRE VOLUME HAD BEEN INFUSED. THE ANESTHESIOLOGIST WAS ABLE TO DUPLICATE THIS WITH SALINE FOR THE CUSTOMER. CUSTOMER STATES SHE (HEALTH PROFESSIONAL) CHOSE "CHANGE SYRINGE" ON THE PUMP, HIT START AND THE SALINE JUST "POURED RIGHT OUT". CUSTOMER WAS NOT ABLE TO DUPLICATE THIS HIMSELF, IT IS SUSPECTS IT COULD BE USER ERROR BUT THE PUMP WILL STILL BE EVALUATED TO MAKE SURE IT IS FUNCTIONING PROPERLY. NO PATIENT HARM DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926857 ↗