Perfusor® 8713032URecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964797965), received between Jul 21, 2022 and Mar 31, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (6 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-2437-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: "PUMP WAS PROGRAMMED AS USUAL TO RUN 2 MCG/KG BOLUS × 10 MIN, FOLLOWED BY 1 MCG/KG/H INFUSION. THE CHILD WAS SEDATED AS EXPECTED. BEFORE TRANSFERRING INTO THE MRI, (B)(6) CHECKED THE PUMP AND NOTICED IT DID NOT BEEP (IT SHOULD BEEP AFTER 10 MIN AND AUTOMATICALLY SWITCH TO THE MAINTENANCE INFUSION). THE BOLUS WAS STILL RUNNING AFTER 10 MIN. SHE MANUALLY SWITCHED IT TO THE INFUSION. THE PUMP INDICATED THE PATIENT RECEIVED 2.338 OF 2 MCG/KG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743157 ↗
• MalfunctionSep 17, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY:DURING AN ON-SITE INTEGRATION WORKFLOW EVENT WITH ORACLE HEALTH, THE NICU NURSE EDUCATOR AT EPCH REPORTED OCCASIONS IN WHICH PERFUSOR SYRINGE PUMPS INFUSED VOLUMES THAT WERE SIGNIFICANTLY LESS THAN EXPECTED. FOR EXAMPLE, IF THE NURSE ANTICIPATED THAT 45 ML SHOULD HAVE INFUSED BY A CERTAIN TIME, THE PUMP ONLY INFUSED 38 ML. NURSE EDUCATOR UNABLE TO DEFINE SPECIFIC PUMP, PATIENT, MEDICATION, OR DATE/TIME DETAILS, CITING MULTIPLE RECENT INSTANCES OF THESE CHALLENGES. SHE REPORTED THAT NURSES HAVE PULLED IMPACTED PUMPS FROM CIRCULATION FOR BIOMED INSPECTION, BUT THE ISSUE HAS OCCURRED REPEATEDLY. THE EDUCATOR INDICATED THAT THIS ISSUE IS OFTEN DETECTED WITH NARCOTICS DUE TO THE CLOSE MONITORING ASSOCIATED WITH THE INFUSIONS. SHE DENIED THE OCCURRENCE OF OCCLUSION ALARMS IN THESE CASES. ADVISED TO SEND IMPACTED DEVICES TO BIOMED FOR FURTHER INVESTIGATION UPON NEXT EVENT (IF APPLICABLE) AND TO REPORT SPECIFIC DETAILS FOR ADDITIONAL ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075950 ↗
• MalfunctionDec 2, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: UNIT WAS REPORTED DUE TO EXPERIENCING OVER INFUSION ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817627 ↗
• MalfunctionNov 14, 2024Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A PERFUSOR® SPACE® SYRINGE PUMP (MATERIAL # 8713032U, BATCH # 97034033F2, SERIAL # (B)(6)) WAS BEING USED TO ADMINISTER MAINTENANCE FLUIDS, SPECIFICALLY D10 AT A RATE OF 80 MILLILITERS PER KILOGRAM PER DAY (ML/KG/DAY). ACCORDING TO THE COMPLAINANT, THE PATIENT, A 4-HOUR-OLD NEONATE, DIAGNOSED WITH RESPIRATORY DISTRESS SYNDROME (RDS) WITH TRANSIENT TACHYPNEA OF THE NEWBORN (TTN), WAS BEING TRANSPORTED VIA RW TRANSPORT. DURING THE TRANSPORT, THE SYRINGE PUMP WAS POSITIONED BESIDE THE ISOLETTE ON THE STANDARD MOUNTING SYSTEM. NO ISSUES WERE OBSERVED PRIOR TO PLACING THE INFANT IN THE ISOLETTE. HOWEVER, FOLLOWING THIS TRANSITION AND WHILE MOVING TO THE VEHICLE, A PATIENT SIDE OCCLUSION ALARM ACTIVATED. THE OCCLUSION WAS IDENTIFIED AS A KINK IN THE INTRAVENOUS (IV) EXTENSION ARM. THE ALARM WAS ABLE TO BE CLEARED WITHOUT ISSUE, AND THEN THE PUMP WAS SUCCESSFULLY RESTARTED. HOWEVER, FOLLOWING THE INFUSION RESTART, THE PUMP DISPLAYED A TOTAL VOLUME TO BE INFUSED (VTBI) OF 0.66ML. PRIOR TO THE ALARM AND RESTART, THE VTBI WAS NOTED AS BEING 1.6ML. NO FURTHER ALARMS, ISSUES, OR DISCREPANCIES NOTED DURING TRANSPORT AND PRIOR TO HAND- OFF. NO VISIBL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683403 ↗
• MalfunctionApr 3, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: NURSING DIRECTOR KAREN LINDELL REPORTED UNINTENDED VOLUME DELIVERED TO PEDIATRIC PATIENT WITH THE USE OF EPIC/B. BRAUN PUMP INTEGRATION: "UPON ROUNDING ON PATIENT, THE RN NOTICED 500 ML NS BAG ON PUMP WAS NEARING EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035664 ↗
• MalfunctionFeb 21, 2024Excess 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: PROPOFOL PUMP NOT DOSING PROPERLY AND BLOOD BACKING UP INTO THE TUBING. PHARMACIST TRIED TO REPROGRAM THE PUMP AND IT WOULD NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753272 ↗
• MalfunctionJul 21, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: THE SYRINGE PUMP INFUSED THE RIGHT VOLUME, BUT JUST AT A FASTER TIME THEN WHAT WAS WANTED. PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15078140 ↗