Perfusor® 8713031URecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 04046964797958), received between Mar 17, 2021 and Sep 16, 2026 — classified as 21 deaths, 4 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (39 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-2434-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791876 ↗
• MalfunctionAug 12, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227733 ↗
• MalfunctionAug 12, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220959 ↗
• MalfunctionAug 3, 2026Device Alarm System; Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122216 ↗
• MalfunctionJul 14, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817266 ↗
• MalfunctionJul 14, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817183 ↗
• MalfunctionJul 7, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: DURING A B. BRAUN/ORACLE INTEGRATION GO-LIVE EVENT, A NURSE REPORTEDLY AUTO-PROGRAMMED AN INTERMITTENT PERFUSOR INFUSION WITH A VOLUME OF 0.43 ML, AND WHEN THE PUMP INDICATED THAT THE INFUSION WAS COMPLETE VIA SYRINGE END, THE FULL VOLUME OF 0.43 ML REMAINED IN THE SYRINGE PER VISUAL INSPECTION. IN THE ORACLE EHR, AN INFUSED VOLUME OF 0.42 ML WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25733348 ↗
• MalfunctionJun 2, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: OVERINFUSION OF MED. RN IN PICU PROGRAMMED BD 30ML SYRINGE (SELECTED CORRECT DISPOSABLE) 25% ALBUMIN TO INFUSE AT A RATE OF 6.5ML/HR, VTBI 13ML. MED INFUSED IN 1 HR 20 MIN, RATHER THAN EXPECTED 2 HRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361090 ↗
• MalfunctionMay 22, 2026Insufficient Flow or Under Infusion

  ACCORDING TO THE COMPLAINANT, DURING AN INFUSION IN (B)(6) 2026, THE INFUSION PUMP UNDER UNFUSED AND DID NOT COMPLETE DELIVERY OF THE PROGRAMMED MEDICATION VOLUME. REPORTEDLY, APPROXIMATELY 6 MILLILITERS (ML) OF MEDICATION REMAINED IN THE SYRINGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260545 ↗
• MalfunctionMay 20, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: SN (B)(6). PUMP WAS UNDER INFUSING, "PUMP DOES NOT COMPLETE THE DOSAGE OF THE MEDICATION". NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232070 ↗
• InjuryMay 12, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: ANESTHESIOLOGIST BEGAN ANESTHESIA INDUCTION AND SHORTLY AFTER NOTED THAT THE PATIENT STARTED SEIZING. PATIENT WAS EMERGENTLY INTUBATED TO PROTECT THE AIRWAY, WAS STABILIZED AND SURGERY WAS ABLE TO BE COMPLETED. POST-OPERATIVELY PATIENT REMAINED INTUBATED AND REMAINED IN ICU OVERNIGHT. THE PATIENT WAS EXTUBATED IN THE MORNING AND REPORTS ARE THAT THERE ARE NO SIGNS OF IMPAIRMENT. BASED ON A REVIEW OF THE KEYBOARD HISTORY AND DEVICE HISTORY REPORTS BIOMED OBTAINED FROM THE PUMP, THE PUMP WAS PROGRAMMED STARTING AT 2:17 PM AND AT 2:18 PM THE SYRINGE HOLDER WAS OPENED. THERE IS NO DATA UNTIL 2:54 PM AT WHICH TIME THERE WAS AN ERROR FOLLOWED BY SYRINGE BRAND AND SIZE WAS SELECTED WITH A SYRINGE FAULT ERROR.

  Patient problems: Convulsion/Seizure

  MAUDE report 25148298 ↗
• MalfunctionMay 4, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: DEFECTIVE EER WAS PLACED VOLUME WAS NOT INFUSED BUT STATING IT WAS ALL DONE WITH INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071833 ↗
• MalfunctionApr 10, 2026Device Difficult to Setup or Prepare; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: RECOGNIZING WRONG SYRINGE SIZE EQUAL PT NOT RECEIVING FULL DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844480 ↗
• InjuryMar 30, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: ANESTHESIOLOGIST BEGAN ANESTHESIA INDUCTION AND SHORTLY AFTER NOTED THAT THE PATIENT STARTED SEIZING. PATIENT WAS EMERGENTLY INTUBATED TO PROTECT THE AIRWAY, WAS STABILIZED AND SURGERY WAS ABLE TO BE COMPLETED. POST-OPERATIVELY PATIENT REMAINED INTUBATED AND REMAINED IN ICU OVERNIGHT. THE PATIENT WAS EXTUBATED IN THE MORNING AND REPORTS ARE THAT THERE ARE NO SIGNS OF IMPAIRMENT. BASED ON A REVIEW OF THE KEYBOARD HISTORY AND DEVICE HISTORY REPORTS BIOMED OBTAINED FROM THE PUMP, THE PUMP WAS PROGRAMMED STARTING AT 2:17 PM AND AT 2:18 PM THE SYRINGE HOLDER WAS OPENED. THERE IS NO DATA UNTIL 2:54 PM AT WHICH TIME THERE WAS AN ERROR FOLLOWED BY SYRINGE BRAND AND SIZE WAS SELECTED WITH A SYRINGE FAULT ERROR.

  Patient problems: Convulsion/Seizure

  MAUDE report 24716695 ↗
• MalfunctionMar 10, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: SYRINGE IS INVOLVED IN AN INCIDENT FOR INFUSED TOO FAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561398 ↗
• MalfunctionMar 5, 2026Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, AFTER ASSUMING CARE OF INFANT MRN, LIPID INFUSION WAS PROGRAMMED AT THE ORDERED RATE AND VERIFIED WITH ANOTHER NURSE (RN). AT APPROXIMATELY 1740, THE INFUSION PUMP INDICATED THAT THE LIPID INFUSION WAS COMPLETE. UPON ASSESSMENT, IT WAS NOTED THAT APPROXIMATELY 60 MILLILITERS (ML) OF LIPIDS HAD INFUSED DESPITE THE CORRECT RATE BEING PROGRAMMED AND VERIFIED. AT THAT TIME, ALL INFUSION PUMPS IN USE WERE BLINKING BLUE AND DISPLAYING A MESSAGE INDICATING THAT THE PUMP REQUIRED AN UPDATE. THE PROVIDER, CHARGE NURSE, AND TRANSPORT NURSE WERE PROMPTLY NOTIFIED OF THE DISCREPANCY. PER PROVIDER ORDERS, THE LIPID INFUSION WAS DISCONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521197 ↗
• MalfunctionJan 9, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: NURSE GAVE PIPTAZO 3G (TOTAL VOLUME 15ML) IN BD SYRINGE 30ML. WHEN END OF INFUSION ALARM OCCURRED, NURSE NOTICED 4ML OF MEDICATION STILL IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022047 ↗
• MalfunctionJan 7, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: NURSE GAVE PIPTAZO 3G (TOTAL VOLUME 15ML) IN BD SYRINGE 30ML. WHEN END OF INFUSION ALARM OCCURRED, NURSE NOTICED 4ML OF MEDICATION STILL IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995463 ↗
• MalfunctionJan 6, 2026Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: PUMP INFUSED AT A RATE ABOVE THE DRUG'S HARD MAX DOSE LIMIT IN THE DRUG LIBRARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973328 ↗
• MalfunctionNov 19, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PATIENT WAS RECEIVING VANCOMYCIN TO ADMINISTER FOR 3 HOURS VIA B BRAUN SYRINGE PUMP. PATIENT ENDED UP GETTING THE MEDICATION IN A MATTER OF 5 MINUTES RUNNING VIA VIA VENOUS PORT ON DIALYSIS MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595291 ↗
• MalfunctionNov 14, 2025Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: EVALUATED AND FOUND INFUSION TIME IS CORRECT TO INFUSE 0.86 ML OVER LESS THAN 6 HOURS AT 0.15 ML/HR. IF RAN AT 0.14 ML/HR THE INFUSION WOULD RUN 6 HOURS AND 9 MINUTES WHICH EXCEEDS THE ENTERED INFUSION TIME. PUMP REMAINS IN CIRCULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559718 ↗
• MalfunctionOct 23, 2025Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: "NIPRIDE GTT ORDERED TO BE INCREASED. THIS RN ATTEMPTING TO SCAN SYRINGE FOR EPIC MAR DOCUMENTATION, BARCODE WAS UNABLE TO BE SCANNED AND THIS RN NEEDED TO ROTATE SYRINGE TO SCAN. LINE CLAMPED, AND SYRINGE SCANNED. PUMP REPROGRAMMED AND SYRINGE REPLACED. WHEN LEVER REACHED END OF SYRINGE, GAVE SMALL "TAP" TO END OF SYRINGE, RESULTING IN SMALL BOLUS OF NIPRIDE REACHING PATIENT. PATIENT BLOOD PRESSURE DROPPED TO 40/20S PER ARTERIAL LINE."

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23367803 ↗
• MalfunctionOct 23, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: NURSE REPORTS USING DRUG LIBRARY ENTRY AND THAT THE 5ML OF MEDICATION WAS TO BE ADMINISTERED OVER 5 MINUTES. NURSE ASKED HER COLLEAGUE TO DOUBLE-CHECK HER PROGRAMMING AS IT WAS HER FIRST TIME USING THE PERFUSOR. DRUG ADMINISTERED OVER 1 MINUTE AS PER NURSE (AS OPPOSED TO THE 5 MINUTES THAT HAD BEEN PROGRAMMED). THE DRUG LIBRARY HAS A LOWER HARD LIMIT OF 2 MINUTES FOR THE MINIMAL TIME OF INFUSION. THE MEDICATION SHOULD NOT HAVE INFUSED ON ONLY ONE MINUTE IF DRUG LIBRARY USED. NO ADVERSE REACTION OF THE PATIENT MENTIONED BY THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367556 ↗
• MalfunctionOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: POTENTIAL CONTRIBUTION OF PUMP TO THE IV INFILTRATION AND SUBSEQUENT COMPARTMENT SYNDROME THAT RESULTED IN PATIENT NEEDING A FASCIOTOMY. MORE INFORMATION TO COME PENDING CUSTOMER SENDING ANSWERS TO ADDITIONAL QUESTIONS. MAJOR CONCERN IS NOT RECEIVING A DOWNSTREAM OCCLUSION ALARM BUT CUSTOMER RECOGNIZED PUMP IS MEASURING PRESSURE IN LINE DOWN THROUGH IV NOT IN SURROUNDING AREA.

  Patient problems: Compartment syndrome; Infiltration into Tissue

  MAUDE report 23367228 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: POTENTIAL CONTRIBUTION OF PUMP TO THE IV INFILTRATION AND SUBSEQUENT COMPARTMENT SYNDROME THAT RESULTED IN PATIENT NEEDING A FASCIOTOMY. MORE INFORMATION TO COME PENDING CUSTOMER SENDING ANSWERS TO ADDITIONAL QUESTIONS. MAJOR CONCERN IS NOT RECEIVING A DOWNSTREAM OCCLUSION ALARM BUT CUSTOMER RECOGNIZED PUMP IS MEASURING PRESSURE IN LINE DOWN THROUGH IV NOT IN SURROUNDING AREA.

  Patient problems: Compartment syndrome; Infiltration into Tissue

  MAUDE report 23367192 ↗