Infusomat® 8713051URecalls & reported problems

Summary

The FDA's MAUDE database contains 531 adverse event reports that list this exact device (DI 04046964660887), received between Nov 18, 2016 and Sep 25, 2026 — classified as 28 deaths, 72 injuries, 431 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (235 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 21, 2023Open, Classified

   Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

   Z-0123-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 531 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fail-Safe Did Not Operate

  As reported by the user facility: Failed to detect air bubble when used on patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896171 ↗
• MalfunctionSep 16, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791879 ↗
• MalfunctionSep 16, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791878 ↗
• MalfunctionSep 16, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791877 ↗
• MalfunctionAug 24, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404987 ↗
• MalfunctionAug 3, 2026Fail-Safe Did Not Operate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123763 ↗
• MalfunctionAug 3, 2026Fail-Safe Did Not Operate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123762 ↗
• MalfunctionJul 29, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072543 ↗
• MalfunctionJul 27, 2026Device Alarm System; Fail-Safe Did Not Operate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008331 ↗
• MalfunctionJul 17, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25853875 ↗
• MalfunctionJul 10, 2026Device Alarm System; Failure to Charge; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787014 ↗
• MalfunctionJun 26, 2026Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: K 20 MEQ/50 ML BAG PROGRAMMED THROUGH THE PUMP TO RUN OVER 1 HOUR. MED HUNG AS SECONDARY, PRIMARY LINE CLAMPED DURING INFUSION. PUMP ALARMING FOR UPSTREAM OCCLUSION AROUND 30 MIN INTO INFUSION TIME. FOUND WHOLE BAG OF K HAD INFUSED INTO THE PATIENT IN APPROXIMATELY 30 MIN. MD NOTIFIED, NO RHYTHM CHANGES NOTED ON MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640746 ↗
• InjuryJun 17, 2026Excess Flow or Over-Infusion

  AS REPORTED IN MEDSUN REPORT (B)(4), A NURSE HUNG 20 MEQ KCL (50ML BAG) TO INFUSE OVER 60 MINUTES. WHEN RN (REGISTERED NURSE) RETURNED, THE ENTIRE BAG HAD INFUSED WITHIN ABOUT 5 MINUTES. CALCIUM GLUCONATE 2 GM IV ADMINISTERED TO PREVENT LIFE THREATENING ARRHYTHMIA OR DEATH. PATIENT DID NOT EXPERIENCE COMPLICATIONS. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2025-00020, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 03FEB2025. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536088 ↗
• MalfunctionJun 17, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: VASOPRESSIN WAS PROGRAMMED AT 0.03 UNITS/HR (3ML/HR) AT 1129 ON (B)(6) 2026. THE MEDICATION INFUSED FASTER THAN INTENDED COMPLETING AT 1748.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533690 ↗
• MalfunctionJun 17, 2026Fail-Safe Did Not Operate

  AS REPORTED BY THE USER FACILITY: "DURING CODE, NO B BRAUN PUMPS WERE ALARMING WITH "DOWNSTREAM OCCLUSION" EVEN THOUGH VASOACTIVE GTTS WERE NOT GETTING TO PATIENT DUE TO THE BACKFLOW OF THE LIPIDS. LIPID B BRAUN PUMP NEVER ALARMED THAT PRESSURE WAS BUILDING TO CUE BACKFLOW INTO GTT LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533336 ↗
• MalfunctionJun 11, 2026Excess Flow or Over-Infusion; Mechanical Jam

  AS REPORTED BY THE USER FACILITY: RAPID INFUSED ON CUSTOMER, DRIVE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470523 ↗
• MalfunctionJun 11, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: INFUSION FINISHED FASTER THAT IT WAS PROGRAMMED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470506 ↗
• MalfunctionJun 9, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PATIENT WAS ORDERED TO HAVE CEFEPIME 2G IN 50 ML D5W RUNNING AT 16.7 ML/HR (WHICH WOULD EQUAL APPROXIMATELY 3 HOUR RUN TIME). RN HUNG UP A SCHEDULED DOSE AT 17:12 THIS EVENING WITH THE PUMP SETTINGS REFLECTINGEXPECTED INFUSION TIME. AT 19:12 DURING BEDSIDE SHIFT REPORT, SHENOTICED THAT THE BAG WAS COMPLETELY INFUSED WITH APPX 1 HOUR REMAINING ON THE PUMP, NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448843 ↗
• MalfunctionJun 5, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: PATIENT WAS ON BYPASS AND PUMP WENT INTO ERROR MESSAGE 2042. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412017 ↗
• MalfunctionJun 2, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PATIENT WAS ORDERED IV AMIODARONE MAINTENANCE INFUSION, FIRST BAG HUNG UP AT 18:31AND IT WAS PROGRAMMED TO INFUSE AT 1 MG/MIN (33.33 ML/HR) WITH A TOTAL VOLUME OF 200 ML. AT 21:11, THE IV PUMP ALARMED AND INDICATING THE BAG WAS EMPTY. HOWEVER, DURING THE BAG CHANGE, RN NOTED THAT THE BAG WAS COMPLETELY EMPTY SOONER THAN EXPECTED AND SHOULD HAVE HAD REMAINING VOLUME AT THAT TIME CAUSING AN OVER INFUSION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25362132 ↗
• MalfunctionJun 2, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: PUMP WOULD NOT DETECT THE PRESSURE INCREASE IN THE TRANSFER SET; SOME VIDEOS DEMONSTRATE A VISIBLE PRESSURE BUILDUP IN THE SET (CLOSED-OFF VENT ON DRIP CHAMBER) WITHOUT TRIGGERING AN ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361361 ↗
• MalfunctionJun 2, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PUMP WAS SETUP FOR A PRIMARY AND SECONDARY INFUSIONS. AT APPROXIMATELY 1900, THIS RN NOTICED THAT THERE MAY HAVE BEEN A MALFUNCTION WITH BRAUN PUMP. THE IV PUMP WAS PROGRAMMED TO DELIVER PIPERACILLIN-TAZOBACTAM (ZOSYN) 3.375 GRAM IN SODIUM CHLORIDE 0.9% (NS) 50 ML IVPB AT 12.5 ML/HR AND STARTED AT 17:53. AT SHIFT CHANGE APPROXIMATELY ONE HOUR LATER, THIS RN FOUND THE IV BAG EMPTY, WHICH WAS INCONSISTENT WITH THE EXPECTED REMAINING VOLUME. THIS SUGGESTED THE PUMP MAY HAVE INFUSED THE MEDICATION AT A RATE DIFFERENT FROM WHAT WAS ORIGINALLY PROGRAMMED AND VERIFIED. THE INFUSION WAS STOPPED, THE CHARGE RN WAS NOTIFIED, AND THE PUMP AND MEDICATION BAG WERE REMOVED FROM PATIENT'S ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360922 ↗
• MalfunctionJun 2, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: NURSE WAS RUNNING PROGRAF ON A PUMP, THEN HUNG THE NEXT BAG. WHEN SHE HUNG THE NEXT BAG, SHE CHANGED THE VTBI WHICH THEN CHANGED THE RATE. THE BAG EMPTIED IN 25 MINUTES. IT LOOKS LIKE THE NURSE CHANGED THE MINUTES TO 25 THINKING SHE WAS CHANGING THE VOLUME TO 250 ML. I ASKED THE CHARGE NURSE TO TAG IT AND SEND IT TO BIOMED, BUT IT WAS NOT BEING DONE WHEN I LEFT THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360615 ↗
• MalfunctionMay 22, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: ICU HEART/ECMO RN REPLACING PATIENT'S POTASSIUM CHLORIDE IV PIGGYBACK. 20MEQ KCL TO INFUSE OVER 60 MINUTES INTEGRATED MEDICATION RN LOOKED UP TO ENSURE PROPER FLOW AND ORDER INTEGRATION WAS SENT (FRESH POST-OP INTUBATED OPEN-HEART PATIENT). NOTED TO SEE ENTIRE 50ML BAG OF KCL EMPTY. IMMEDIATELY STOPPED PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260807 ↗
• MalfunctionMay 22, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: WHILE RN INFUSING KCI RIDER VIA IVPB, NOTED KCL FREE FLOWING. ICU MANAGER HAPPENS TO BE IN ICU SOUTH DURING THIS EVENT. RN'S STOPPED PUMP AND IMMEDIATELY DISCONNECTED AND ROLLER CLAMPED TUBING. APPEARS TO HAVE KCL FLOWING INTO PRIMARY VS DOWN PRIMARY TUBING AS RN'S MGR DISCONNECTED AND TESTING WHERE KCI WAS FREE FLOWING INTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260806 ↗