Outlook® 621-400ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 04046964186547), received between Feb 23, 2017 and Feb 27, 2023 — classified as 2 deaths, 2 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (24 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRAUN SYRINGE PUMP LOADED, SYRINGE PUMP FAILED TO RECOGNIZE SYRINGE AND DELIVERED ENTIRE VOLUME. SYRINGE WAS NOT CONNECTED TO PATIENT. NO INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442132 ↗
• MalfunctionFeb 27, 2023Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRAUN SYRINGE PUMP LOADED, SYRINGE PUMP FAILED TO RECOGNIZE SYRINGE AND DELIVERED ENTIRE VOLUME. SYRINGE WAS NOT CONNECTED TO PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442079 ↗
• MalfunctionJul 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PRIMARY NURSE (RN) USED DOSE MODE TO PROGRAM FENTANYL WITH CO-SIGNING RN AS PRIMARY MEDICATION. RED SCREEN ON LEFT READ "FENTANYL" AS DRUG NAME. PATIENT TRANSPORTED TO CT SCAN VIA RN AND RENAL THERAPIST. RN RECEIVED PHONE CALL AROUND NOON FROM ICU PROVIDER THAT FAMILY HAD DECIDED TO TRANSITION TO COMFORT MEASURES ONLY AND CT SCAN CANCELED. APPROXIMATELY TWENTY MINUTES LATER ARRIVED BACK TO UNIT WITH PATIENT. 30 MINUTES LATER, DOSE INCREASED TO 37.5 MCG/HR. AN HOUR LATER RN ENTERED ROOM DUE TO IV PUMP ALARMING INFUSION COMPLETE (FENTANYL). FOUND FENTANYL RUNNING AT 37.5ML/HR, PER MEDICATION ADMINISTRATION RECORD (MAR) SHOULD HAVE BEEN RUNNING AT 37.5 MCG/HR FOR A RATE OF 1.9ML/HR. ICU PROVIDER INFORMED OF ABOVE. COSIGNING RN AWARE OF ABOVE. PUMP IMMEDIATELY SEQUESTERED. FENTANYL INFUSION PLACED ON NEW PUMP WITH NEW BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092678 ↗
• MalfunctionSep 24, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: THERE MAY HAVE BEEN AN OVERINFUSION EVENT WITH THE PUMP. NO OTHER INFORMATION IS AVAILABLE AND THEY WOULD LIKE THE PUMP TO BE EVALUATED AS A PRECAUTION. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526837 ↗
• DeathAug 26, 2021Excess Flow or Over-Infusion; Free or Unrestricted Flow; Excess Flow or Over-Infusion; Free or Unrestricted Flow

  AS REPORTED ON MW5103031: A PATIENT WAS TRANSITIONED TO HOSPICE/COMFORT CARE STATUS AND WAS TO BE TERMINALLY EXTUBATED. A HYDROMORPHONE 50MG/50 ML DRIP WAS ORDERED FOR THE PATIENT TO BE TITRATED TO COMFORT WITH A STARTING RATE OF 1MG/HR. A B. BRAUN OUTLOOK 400ES MODEL IV PUMP WAS PROGRAMMED CORRECTLY, THE PUMP BEGAN TO ALARM TO "CHECK SET." THE RN ATTEMPTED TO TROUBLESHOOT WHY THE PUMP WAS ALARMING BUT THE PUMP KEPT DISPLAYING THE ALERT TO "CHECK SET." DESPITE THE PUMP BEING PROGRAMMED CORRECTLY, THE MEDICATION FLOWED VIA GRAVITY INTO THE PATIENT'S IV UNTIL THE IV BAG WAS EMPTY. THE RN ASSESSED THE PATIENT. THE PATIENT WAS STILL IN RESPIRATORY DISTRESS. RN DID NOT BELIEVE THE PATIENT RECEIVED ALL OF THE MEDICATION, BELIEVING MOST OF THE DRUG WAS STILL IN THE IV LINE AS THE B. BRAUN PUMP TUBING HOLDS ROUGHLY 27 ML OF DEAD SPACE. RN PROCURED ANOTHER BAG OF HYDROMORPHONE 50MG/50ML, CHECKED THE PUMP AGAIN AND HUNG THE BAG. THIS BAG ALSO FREE FLOWED INTO THE PATIENT WHILE PUMP ALARMED "CHECK SET." AFTER THIS SECOND BAG FLOWED IN, RN SUSPECTED A PUMP MALFUNCTION AND ALERTED HER MANAGER. THE PUMP WAS REMOVED FROM SERVICE AND SENT TO CLINICAL ENGINEERING FOR INSPECTION. THE RN INSPECTED TH

  Patient problems: Adult Respiratory Distress Syndrome

  MAUDE report 12372498 ↗
• MalfunctionJun 29, 2021Temperature Problem; Temperature Problem

  AS REPORTED BY THE USER FACILITY: AN IV PUMP WAS PLUGGED INTO THE BACK OF THIS IV PUMP. THE PLUG FROM THE OTHER IV PUMP BEGAN TO SMOKE DAMAGING THAT PUMP'S PLUG AND THE OUTLET IN THIS PUMP. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082765 ↗
• MalfunctionJun 23, 2021Temperature Problem; Temperature Problem

  AS REPORTED BY THE USER FACILITY: THE IV PUMP WAS PLUGGED INTO THE BACK OF ANOTHER IV PUMP. THE PLUG BEGAN TO SMOKE DAMAGING THE PUMP PLUG AND THE OUTLET IN THE OTHER PUMP. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048125 ↗
• MalfunctionMay 6, 2021Temperature Problem; Temperature Problem

  AS PER REPORTED BY THE USER FACILITY: PUMP BEGAN TO SMOKE AND THERE WAS BLACK CHARRING AROUND THE OUTLET. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782821 ↗
• MalfunctionFeb 4, 2021Pumping Stopped; Pumping Stopped

  AS REPORTED BY THE USER FACILITY: THE PUMP STOPPED INFUSING ON ITS OWN DURING A A PATIENT INFUSION. IT COULD NOT BE CLARIFIED IF THERE WAS A POWER FAILURE, IF SOMEONE HIT STOP OR IF IT UNDER-INFUSED. THE FACILITY REQUESTED THE EVENT HISTORY AND KEY STROKE HISTORY BE REVIEWED TO DETERMINE WHY THE PUMP STOPPED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278925 ↗
• MalfunctionNov 13, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS PER REPORTED BY THE USER FACILITY: AN IV INFUSION OF POTASSIUM PHOSPHATE INFUSED IN 1.5 HOURS INSTEAD OF 6 HOURS. THE PUMP WAS EVALUATED BY THE FACILITY'S BIOMEDICAL ENGINEERING AND NO ISSUES WERE FOUND. THEY ALSO REVIEWED REPORTS AND LOGS AND THE PUMP APPEARS TO HAVE BEEN PROGRAMMED APPROPRIATELY. THEY ARE REQUESTING THE PUMP BE EVALUATED BY B. BRAUN MEDICAL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835866 ↗
• MalfunctionAug 20, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: THE PUMP OVERINFUSED A PATIENT'S MEDICATION. IT WAS STATED THE NURSE HUNG A 100ML IV BAG CONTAINING HYDROMORPHONE AT 2319 AND SET THE RATE AT 2.5ML/HOUR AND THE PUMP WAS LOCKED. AT 0430 THE PATIENT FELL OUT OF BED AND WHEN THE NURSE RESPONDED THE IV BAG WAS EMPTY. THE REMAINING VOLUME ON THE PUMP WAS 89ML.

  Patient problems: Fall; No Known Impact Or Consequence To Patient

  MAUDE report 10430108 ↗
• DeathAug 4, 2020Excess Flow or Over-Infusion; Improper Flow or Infusion; Excess Flow or Over-Infusion; Improper Flow or Infusion

  AS PER REPORTED BY THE USER FACILITY: THE MIDDLE ALIGNMENT PIN ON THE PUMP WAS MISSING AND THE DRUG (DILAUDID) FREE-FLOWED CAUSING AN OVERINFUSION. THE DOSE WAS SUPPOSED TO BE 1ML/HR AND A FULL 50ML FREE-FLOWED. NO LEAKS OR WET AREAS WERE NOTED SO IT IS BELIEVED THE PATIENT RECEIVED THE MEDICATION. THE PATIENT TOLERATED THE FULL DOSE. THE PUMP ALARMED TO CHECK THE SET THREE TO FOUR TIMES. THE DRIP WAS DISCONTINUED. PATIENT DID HAVE A DROP IN BLOOD PRESSURE AND RESPIRATORY RATE. ABOUT 2.5 HOURS LATER THE PATIENT BECAME AGITATED AND A NEW OPIOID DRIP WAS STARTED ON A DIFFERENT PUMP. THE PATIENT DID PASS AWAY A SHORT TIME LATER.

  Patient problems: Death; Decreased Respiratory Rate; Low Blood Pressure/ Hypotension

  MAUDE report 10362631 ↗
• MalfunctionFeb 12, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS PER REPORTED BY THE USER FACILITY: A NURSE HUNG A 100CC BAG OF INSULIN AS A SECONDARY INFUSION AND PROGRAMMED THE PUMP TO RUN AT 10CC/HOUR. THE NURSE WENT BACK 30 MINUTES LATER AND THE ENTIRE BAG HAD INFUSED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699693 ↗
• MalfunctionJan 17, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  AS PER REPORTED BY THE USER FACILITY: A PATIENT CALLED OUT TO STATE HER IV PUMP WAS MAKING A STRANGE NOISE AND SHE SAW SMOKE AND SMELLED A BURNING SMELL COMING FROM THE IV PUMP MACHINE. IT WAS REPORTED A SMALL FIRE WAS NOTICED IN THE LOAD SET AREA OF THE IV PUMP. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9601062 ↗
• MalfunctionMay 9, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS PER REPORTED BY THE USER FACILITY: THEY RECENTLY HAD A MEDICATION ERROR IN THE EMERGENCY DEPARTMENT THAT RESULTED FROM THEIR CURRENT IV PUMP PROGRAMMING. THE PUMPS ARE CURRENTLY SET TO DEFAULT BACK TO WHATEVER HAD BEEN PREVIOUS PROGRAMMED AND PULL IN INFORMATION, LIKE THE PATIENT'S WEIGHT, WHEN THEY ARE FIRST TURNED ON TO START AN INFUSION. AS A RESULT, WE HAD A (B)(6) KG PATIENT THAT ACCIDENTLY RECEIVED A MEDICATION DOSED AT A WEIGHT OF (B)(6) KG, POTENTIALLY UNDER-DOSING THEM. THE PATIENT WAS ADMINISTERED PROPOFOL. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595932 ↗
• MalfunctionFeb 19, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS PER REPORTED BY THE USER FACILITY: IT WAS REPORTED BY THE CUSTOMER'S BIOMED THAT IT TOOK LONGER THAN IT SHOULD HAVE TO DELIVER THE MEDICATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350561 ↗
• MalfunctionJan 30, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS PER REPORTED BY THE USER FACILITY: IT WAS REPORTED WHEN DOING PREVENTIVE MAINTENANCE (PM) THE VOLUME WAS OFF BY 10% AND THERE WERE ERRORS 93 AND 86. NO PATIENT INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8288802 ↗
• MalfunctionOct 24, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS PER REPORTED BY THE USER FACILITY VIA MEDWATCH (B)(4): IV PIGGYBACK (IVPB) MEDICATION WAS NOT INFUSING AT THE SET RATE ON THE PUMP. THE LINES WERE FLUSHED AND THE TUBING WAS PATENT. REMOVED PUMP FROM SERVICE. MEDICATION WAS INFUSED VIA A DIFFERENT PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999571 ↗
• MalfunctionJun 19, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  AS PER THE USER FACILITY: THE PUMP HAD A BURNING SMELL WITH OVERHEATING. THE TOP CASE WAS BURNED. NO PATIENT INJURY/INVOLVEMENT. THE PUMP IS OPERATIONAL BUT NOT REPAIRED. THERE WAS NO PATIENT INJURY/INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613028 ↗
• MalfunctionJun 15, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS PER THE USER FACILITY: PATIENT WAS RECEIVING CANCER MEDICATION THROUGH PORT WITH IV- MEDICATION - ETOPOSIDE AND NSS FOR FLUSH. THE PUMP RATE WAS SET AT 238 ML/HR AND VOLUME 208 ML. THE RATE WAS SET HIGHER TO ACCOMMODATE THE FLUSH AND THE MEDICATION IS GIVEN IN ONE (1) HOUR AS ORDERED. AFTER 30 MINUTES THE BAG WAS FOUND TO BE INFUSED. THE NURSE CHECKED THE PUMP, CONNECTIONS AND CLAMP. ALL SEEMED TO BE DONE CORRECTLY. PATIENT DID NOT HAVE ANY SIDE EFFECTS. VITAL SIGNS WERE WITHIN NORMAL LIMITS. THE PUMP WAS SENT TO THE FACILITY BIO MED AND FOUND TO HAVE NO DISCREPANCIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604716 ↗
• InjuryFeb 2, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS PER USER FACILITY: NURSE RAN AN INFUSION OF MAGNESIUM (UNKNOWN MANUFACTURER) IN A 500ML BAG (UNKNOWN MANUFACTURER). THE NURSE PROGRAMMED MAGNESIUM AS MAINTENANCE RATE (2G) 50ML/HR AND THEN PROGRAMMED THE LOADING DOSE (4G) 200ML/HR OVER 30 MINUTES. AFTER 30 MINUTES THE PUMP IS TO AUTOMATICALLY BUMP THE INFUSION BACK TO THE LOADING DOSE OF (2G) 50ML/HR. IT DID NOT AND THE PATIENT RECEIVED THE LOADING DOSE (4G) 200ML/HR FOR AN ADDITIONAL HALF HOUR BEFORE THE NURSE RECOGNIZED THE DOSE BEING RUN AT (4G). THE PATIENT RECEIVED A TOTAL OF 1 HOUR INFUSION OF 4 GRAMS MAGNESIUM. THE NURSE IMMEDIATELY STOPPED THE INFUSION AT THE TIME SHE RECOGNIZED THE PATIENT HAD AN OVER INFUSION. THE INCIDENT WAS REPORTED TO THE PHYSICIAN ON (B)(6) 2018. THE PHYSICIAN ORDERED CALCIUM GLUCONATE AS AN ANTIDOTE AND VITALS TO BE MONITORED AND LABS WERE ORDERED. THE NURSE ALSO REPORTED THE INCIDENT TO THE NURSE MANAGER. NO PATIENT IDENTIFIERS WERE GIVEN AND THE PUMP WAS SEQUESTERED TO THE FACILITY'S BIOMED. THE PATIENT HAD NO ILL EFFECTS FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7236649 ↗
• MalfunctionNov 10, 2017Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: CUSTOMER STATED PRIMARY IV SOLUTION WAS SET TO INFUSE A TOTAL VOLUME OF 544 ML AT A RATE OF 362 ML/HR FOR A TOTAL TIME OF 1.5 HOURS FOR A FULL INFUSION OF CHEMOTHERAPY. NO SYSTEM ERRORS OR PUMP ALARMS. AFTER 1.5 HOURS, THE REMAINING VOLUME IN THE IV BAG WAS 267 ML. THE PUMP UNDER INFUSED THE MEDICATION AND THE PUMP WAS REMOVED FROM SERVICE. AN ADDITIONAL PUMP WAS USED TO ADMINISTER THE REMAINING DOSE OF IV THERAPY. NO PATIENT HARM. IV SOLUTION BEING INFUSED WAS CAMPTOSAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7017179 ↗
• MalfunctionOct 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: THE STARTING VOLUME WAS 1 LITER. THE NURSE PROGRAMMED THE PUMP TO INFUSE 533 ML OVER 45 MINUTES. SHE THEN REPROGRAMMED THE PUMP TO INFUSE AT A RATE OF 114 ML/HR FOR THE REMAINING VOLUME. THE PUMP ALARMED "VOLUME INFUSED" 3 HOURS INTO THE SECOND INFUSION (TOTAL RUN TIME 4 HR 12 MIN). THE PUMP DISPLAYED "PUMP NEEDS REPAIR". THE CUSTOMER WAS UNABLE TO SHARE WHAT WAS BEING INFUSED, BUT THEY DID PROVIDE THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958515 ↗
• MalfunctionSep 14, 2017Pumping Stopped; Pumping Stopped

  AS REPORTED BY THE USER FACILITY: EVENT 19 OF 21: OVER A TWO DAY PERIOD, WITHIN A SPECIFIC AREA OF THE HOSPITAL, A TOTAL OF 21 PUMPS DISPLAYED AN ERROR MESSAGE AND THEN FROZE. TWENTY-ONE SEPARATE MDRS ARE BEING FILED FOR THIS EVENT. IT IS KNOWN THAT 16 PUMPS WERE NOT IN USE DURING THE EVENT; HOWEVER, THERE WAS LIMITED INFORMATION REPORTED ON THE REMAINING 5 PUMPS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6864812 ↗
• MalfunctionSep 14, 2017Pumping Stopped; Pumping Stopped

  AS REPORTED BY THE USER FACILITY: EVENT 21 OF 21: OVER A TWO DAY PERIOD, WITHIN A SPECIFIC AREA OF THE HOSPITAL, A TOTAL OF 21 PUMPS DISPLAYED AN ERROR MESSAGE AND THEN FROZE. TWENTY-ONE SEPARATE MDRS ARE BEING FILED FOR THIS EVENT. IT IS KNOWN THAT 16 PUMPS WERE NOT IN USE DURING THE EVENT; HOWEVER, THERE WAS LIMITED INFORMATION REPORTED ON THE REMAINING 5 PUMPS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6864810 ↗