Infusomat® 8713050URecalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 04046963716752), received between Nov 21, 2016 and Jun 19, 2026 — classified as 2 deaths, 6 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (57 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. Aug 7, 2024Open, Classified

   Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

   Z-2972-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.

• DeathJun 19, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: POSSIBLE OVER INFUSION. TWO (2) DAYS AFTER THE REPORTED EVENT OCCURRED THE PATIENT EXPIRED. THE PATIENT HAD BEEN TRANSFERRED TO ANOTHER FACILITY AT THIS POINT. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2020-00092, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 24APR2020. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.

  Patient problems: Insufficient Information

  MAUDE report 25562848 ↗
• MalfunctionApr 21, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PROGRAMMED FOR 1 HOUR. INFUSED IN 28 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942700 ↗
• MalfunctionApr 21, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: SET WITH CORRECT VOLUME AND TIME FOR MEDS OVER 30 MINUTES. INFUSED ALL IN 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942496 ↗
• MalfunctionApr 21, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: PROGRAMMED FOR 570ML AT 1 HOUR. INFUSED OVER A 1 HOUR AND 40 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941229 ↗
• MalfunctionMar 30, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: OVER INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717688 ↗
• MalfunctionMar 6, 2026Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: LEVOPHED 4 MG/250 ML AT 30 MCG/MIN WAS SUPPOSED TO BE GIVEN TO A PATIENT. THE NURSE SAID THE PUMP WAS STARTED, BUT NOTHING WAS INFUSING (NO DRIPS IN THE DRIP CHAMBER AND NOTHING AT THE END OF THE TUBING). AS A SOLUTION, THEY SAID THAT THEY OPENED THE AIR VENT AND WERE ABLE TO SEE DRIPS GOING ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530963 ↗
• MalfunctionJun 2, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: "THERE WAS A DELAY INFUSION INCIDENT REPORT ON THE PUMP, IT'S ALSO DUE SERVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122347 ↗
• MalfunctionMay 30, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: "THE PATIENT WAS PRESCRIBED TAVANIC 500MG 1X1 I.V. ACCORDING TO THE MEDICATION INSTRUCTIONS, THE INFUSION TIME IS 60 MINUTES. THE MEDICATION IS READY FOR USE IN A 100ML SOLUTION. THE MEDICATION WAS ADMINISTERED VIA A DRIP REGULATOR. THE DEVICE WAS PROGRAMMED WITH A RATE OF 100ML/H, A TOTAL VOLUME OF 100ML, AND THE DEVICE CALCULATED THE TIME AS 60 MINUTES. THE PATIENT CALLED THE NURSE AFTER 40 MINUTES BECAUSE THE DEVICE WAS ALARMING. IT WAS OBSERVED THAT THE DRIP REGULATOR HAD ADMINISTERED THE ENTIRE MEDICATION IN 40 MINUTES, WHICH IS 20 MINUTES TOO FAST. THE PATIENT DID NOT EXPERIENCE ANY HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113393 ↗
• MalfunctionMay 30, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: "FRIDAY (B)(6) 2025 1411HR STARTED THERAPY USING PURE HARTMANS SOLUTION VBTI SET AT 500ML @ 1000ML/HR. EXPECTED COMPLETION TIME 1441HR. AT 1443 ALARM KVO ON PUMP. NURSE NOTED THAT THERE IS A CHANGE IN RATE FROM 1000ML TO 500ML. FOUND THAT BAG WAS NOT EMPTY AND HAD SOME LIQUID LEFT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113391 ↗
• MalfunctionMay 29, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: "8700140SP INFUSOMAT SPACE LINE DOSIFIX. SPIKED INTO ADAPTER WHICH IS SPIKED TO THE SOFT BAG CONTAINER. VTBI 110MLS. RATE 4MLS PER HOUR. UNDER RUN OF 5MLS DURING HOURLY CHECK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108392 ↗
• MalfunctionMay 29, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: "INFORMED BY THE NURSE THAT THE INFUSION PUMP WHOSE MEDICATION RAN OUT BEFORE THE EXPECTED END."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104297 ↗
• MalfunctionMay 28, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: NURSES REALISE THAT THE FLUID IN THE PUMP IS STILL COMPLETELY FULL AFTER THE PUMP HAS BEEN RUNNING FOR 6 HOURS. THE PUMP HAS NOT DRAWN ANY FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099353 ↗
• MalfunctionMay 28, 2025Improper Flow or Infusion; Improper Flow or Infusion

  ACCORDING TO THE EVENT DESCRIPTION: THE RUN RATE IS NOT CORRECT, DESPITE CORRECT INPUT THERE IS STILL A LOT OF UNWANTED RESIDUAL VOLUME IN THE INFUSION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099351 ↗
• MalfunctionMay 27, 2025False Alarm; False Alarm

  ACCORDING TO THE EVENT DESCRIPTION: "AS PER NIGHT SHIFT STAFF, THEY NOTED THE PUMP BEEPING TWO TIMES WITH THE ERROR OF 'EMPTY SYRINGE' SHOWED ON THE PUMP. WHEN THE FIRST ERROR BEEPING, THEY CHECKED AND NOTED THE SYRINGE WAS IN PLACE AND CONTINUE THE INFUSION. WHEN SECOND TIME THEY ENCOUNTERED SAME ISSUE, THEY CHANGED ANOTHER SYRINGE PUMP WITH THE EXISTING MEDS RUNNING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088696 ↗
• MalfunctionMay 23, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE EVENT DESCRIPTION: "SUSPECTED OVERINFUSION OF 2.42 MLS FUROSEMIDE PUMP QUARANTINED AT HOSPITAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080973 ↗
• MalfunctionMar 20, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: MACHINE OVER INFUSED - GAVE FULL DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655175 ↗
• MalfunctionMar 18, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: ON (B)(6) 2025 AT 202 6HOURS STAFF STARTED RUNNING PUMP AT A RATE OF 83.33 MILLILITERS AN HOUR (ML/H), INTENDED VOLUME TO BE INFUSED (VTBI) 500 MILLILITERS (ML) FOR 6 HOURS. REPORTEDLY THE INFUSION WAS SUPPOSED TO END AT 0226 HOURS. ON (B)(6) 2025 AT 0230 HOURS THE PUMP SHOWED KEEP VEIN OPEN (KVO) = 0 MILLILITERS (ML) BUT BOTTLE HAS ABOUT 200 MILLILITERS (ML) REMAINING.. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632162 ↗
• MalfunctionMar 7, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE CUSTOMER: "REPORT FROM THE UNIT'S NURSES: CHEMOTHERAPY WAS RUNNING PUMP FINISHED THE MEDICATION BEFORE IT WAS DEFECTIVE. PATIENT:(B)(6) . N/A: (B)(6) BED : 1516 MEDICATION: ETOPOSIDE / VINCRISTINE / DOXORUBIN PERIOD: (B)(6) TO (B)(6) . INITIAL PROGRAMMING: MEDICATION SHOULD RUN IN EXACTLY 24 HOURS. CASE DESCRIPTION: MEDICATION BEGAN , HOWEVER, IT WILL CLOSE . WAS THERE A CLINICAL WORSEMENT: NO THE PATIENT'S CONDITION WORSENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549801 ↗
• MalfunctionMar 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: ON (B)(6) 2025 AT 1955 HOURS THE STAFF KEYED IN RATE: 500 MILLILITERS AN HOUR (ML/H), VOLUME TO BE INFUSED (VTBI): 500 MILLILITERS (ML) AND INTENDED TIME FOR 1 HOUR. PUMP SUPPOSED TO END AT 2055 HOURS. WHEN KVO FINISH, STAFF WENT TO ATTEND AND NOTICE THAT THERE IS STILL HALF A BOTTLE OF MEDICATION IN THE BOTTLE WHEN THE BOTTLE SHOULD BE EMPTY. STAFF TOOK OUT LINE AND PLACED IT BACK AFTER THE INCIDENT. ORANGE ROLLER AND VENT WAS NOT TOUCHED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549793 ↗
• MalfunctionFeb 24, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: ON (B)(6) 2025, AT 0924 HOURS STAFF PUT UP THE 500 MILLILITERS (ML) COMPOUND SODIUM LACTATE, RUNNING AT A RATE OF 41.67 MILLILITERS AN HOUR (ML/H) FOR OVER 12 HOURS, WITH INTENDED VOLUME TO BE INFUSED (VTBI) OF 500 MILLILITERS (ML). AT AROUND 2320 HOURS THE SAME DAY THE PUMP ALARMED AND SHOWED KEEP VEIN OPEN (KVO) 0 MILLILITERS (ML) NEAR END. NURSE SAW THAT THE BAG IS FULL INSTEAD OF EMPTY. NURSE USED THE SAME BAG AND REKEYED IN RATE OF 41.67ML/H FOR OVER 12 HOURS, WITH INTENDED VTBI OF 500ML. ON (B)(6) 2025, AT 1400 HOURS THE PUMP ALARMED AND SHOWEDVFINISH KVO. THE BAG WAS NOTICED TO HAVE AN ESTIMATED REMAINING 400 MILLILITERS (ML) LEFT WHEN IT SHOULD BE EMPTY. STAFF DID NOT TOUCH VENT OR ORANGE ROLLER. LINE WAS NOT CHANGED THROUGHOUT INCIDENT. AIRVENT OF TUBING WAS OBSERVED TO BE KEPT CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21451478 ↗
• InjuryFeb 19, 2025Air/Gas in Device; Air/Gas in Device

  ACCORDING TO THE CUSTOMER: "WE WERE INFORMED A PATIENT PRESENT TO (B)(6) ON (B)(6) 2024 (TIME UNKNOWN) INTO THE ACUTE TREATMENT AREA. THE PATIENT WAS GIVEN IV CRYSTALLOID FLUIDS (ACTUAL FLUID/AMOUNT/RATE ALL UNKNOWN) INFORMED THEY WERE DELIVERED INTO A PERIPHERAL CANNULA VIA THE B.BRAUN INFUSOMAT SPACE PUMP WITH THE SPACE AIRSTOP LINE (LINE OR PUMP). PLEASE NOTE: WE HAVE NO FURTHER INFORMATION REF SERIAL NUMBERS/BATCH NUMBERS. THE CHILD HAD SIGNS OF 2 X CLINICAL SEIZURES, WITH THE LIKELIHOOD OF AN AIR EMBOLISM IN THE BRAIN POST SCANS. HYPERBARIC THERAPY WAS ALSO GIVEN TO THE CHILD, THE CHILD HAS SINCE BEEN DISCHARGED HOME WE WERE ADVISED." 12HOURS.

  Patient problems: Convulsion/Seizure

  MAUDE report 21412849 ↗
• MalfunctionFeb 19, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE EVENT DESCRIPTION: SHORT INFUSION OF 190 ML/H PROGRAMMED WITHOUT TARGET VOLUME. THE MEDICATION HAD A TOTAL VOLUME OF 90 MILLILITERS (ML) (INCL. RINSING VOLUME WITH ONE TIME BOTTLE). NORMALLY THE FIRST INFUSION BOTTLE SHOULD BE SHOULD BE EMPTY AFTER ABOUT 20 MINUTES SO THAT 10 MINUTES REMAIN FOR RINSING. AFTER MORE THAN 30 MINUTES, I NOTICED THAT THE FIRST BOTTLE (65 MILLILITERS (ML)) WAS STILL STILL NOT INSIDE. INFUSION RATE INCREASED TO 260 MILLILITERS AN HOUR (ML/H). THE SECOND INFUSION BOTTLE WITH 30ML SHOULD HAVE BEEN READY IN 7 MINUTES WITH A RUN RATE OF 260 MILLILITERS AN HOUR (ML/H) SHOULD HAVE BEEN READY IN 7 MINUTES. HOWEVER, THE INFUSOMAT NEEDED 20 MINUTES FOR THIS. AFTERWARDS, USING THE SAME INFUSION SET AND A NEW INFUSION BOTTLE INFUSION BOTTLE (NOT ON THE PATIENT). SET A FLOW RATE OF 20 MILLILITERS AN HOUR (ML/H) AND STOPPED AFTER 30MINUTES. INSTEAD OF THE 10 MILLILITERS (ML) THERE WERE ONLY 5 MILLILITERS (ML). POSSIBLE SERIOUS CONSEQUENCES: SHELF LIFE / STABILITY OF THE DRUG HAS BEEN EXCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409771 ↗
• MalfunctionFeb 12, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE CUSTOMER: "EQUIPMENT MALFUNCTIONED WHERE IT MARKED THAT IT HAD INFUSED 130 ML AND HAD INFUSED ABOUT 20 ML." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363239 ↗
• MalfunctionFeb 11, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: ALLEGEDLY, 12 HOURS WERE SET, BUT THE SOLUTION IS SAID TO HAVE RUN THROUGH IN 1 HOUR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355225 ↗
• MalfunctionFeb 11, 2025Inaccurate Delivery; Inaccurate Delivery

  ACCORDING TO THE EVENT DESCRIPTION THERE WAS A DEVIATION GREATER THAN 5% IN THE DELIVERY ACCURACY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354308 ↗