Perfusor® 8713040URecalls & reported problems

B. Braun Medical Inc. · PERFUSOR SPACE ACM-KIT · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963687182), received between May 17, 2018 and Jul 13, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 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

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-2436-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

Excess Flow or Over-Infusion3
Insufficient Flow or Under Infusion1

Patient problems

No Known Impact Or Consequence To Patient3
No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 13, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: EVENT 2: A FENTANYL INFUSION WAS SET TO RUN AT 2MCG/KG/HR, AND WHEN THE PUMP WAS CHECKED AGAIN, PROBABLY WITHIN AN HOUR, THE RATE WAS 7MCG/KG/HR. NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10264702 ↗
MalfunctionJul 13, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: EVENT 1: A FENTANYL INFUSION WAS SET TO RUN AT 2MCG/KG/HR, AND WHEN THE PUMP WAS CHECKED AGAIN, PROBABLY WITHIN AN HOUR, THE RATE WAS 7MCG/KG/HR. NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10264700 ↗
MalfunctionSep 12, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: OVER INFUSION; THE PUMP INFUSED ALL OF THE IRON AT ONCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7868262 ↗
MalfunctionMay 17, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY USER FACILITY: SYRINGE STOPPED INFUSING WITH ADDITIONAL VOLUME TO BE INFUSED. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7522504 ↗

Device details

UDI-DI	`04046963687182`
Brand	Perfusor®
Model	8713040U
Company	B. Braun Medical Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 17, 2022

Device type (GMDN): Bedside syringe pump

A mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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