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Vista® 637-202Recalls & reported problems

B. Braun Medical Inc. · Vista® Basic Large Volume Infusion Pump · Class 2

Quick summary

This B. Braun Vista Basic large volume infusion pump has 85 reports in the FDA database, with no deaths and no injuries recorded. Many reports describe the pump delivering more or less fluid than programmed, and some describe batteries that do not hold charge, false air or blockage alarms, and screens that stop responding. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
85
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 04046963988852), received between Dec 2, 2016 and Nov 26, 2025 — classified as 85 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (38 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 3 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 5 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 3 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 5 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Excess Flow or Over-Infusion38
  • Insufficient Flow or Under Infusion31
  • Fail-Safe Did Not Operate6
  • Infusion or Flow Problem5
  • Failure to Charge4
  • Device Alarm System3
  • Failure to Pump3
  • False Alarm3

Patient problems

  • No Clinical Signs, Symptoms or Conditions32
  • No Known Impact Or Consequence To Patient22
  • No Consequences Or Impact To Patient20
  • No Patient Involvement7
  • No Information2
  • Electric Shock1
  • Headache1
  • Hot Flashes/Flushes1

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 26, 2025False Alarm; Failure to Charge; Failure to Pump; False Alarm; Failure to Charge; Failure to Pump

    AS REPORTED BY THE USER FACILITY: THESE ARE THE ISSUES WITH THE 3 PUMPS BEING REPORTED: SERIAL NR#'S (B)(6). PUMPS DO NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT CONTINUOUSLY SAY 'OCCLUSION' OR 'AIR IN LINE' DESPITE NEITHER OF WHICH REALLY PRESENT. WHEN PRESSING START FOR INFUSION, FREQUENTLY WILL FLASH FROM SEVERAL DIFFERENT SCREENS RANDOMLY AND SUDDENLY NOT WORK. NEED TO TURN OFF AND BACK ON AND RESET. SOMETIMES WILL JUST NOT INFUSE DESPITE EVERYTHING BEING CORRECT. NEED TO TURN OFF AND ON SEVERAL TIMES BEFORE IT EITHER STARTS WORKING OR NEED TO JUST NOT USE PUMP AND RUN BY GRAVITY. PUMP SN: (B)(6) - MDR#: 9610825-2025-00680, PUMP SN: (B)(6) - MDR#: 9610825-2025-00681.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23658857 ↗
  • MalfunctionNov 20, 2025False Alarm; Failure to Charge; Failure to Pump; False Alarm; Failure to Charge; Failure to Pump

    AS REPORTED BY THE USER FACILITY: THESE ARE THE ISSUES WITH THE 3 PUMP BEING REPORTED: SERIAL NR#'S (B)(6). · PUMPS DO NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT · CONTINUOUSLY SAY 'OCCLUSION' OR 'AIR IN LINE' DESPITE NEITHER OF WHICH REALLY PRESENT. · WHEN PRESSING START FOR INFUSION, FREQUENTLY WILL FLASH FROM SEVERAL DIFFERENT SCREENS RANDOMLY AND SUDDENLY NOT WORK. NEED TO TURN OFF AND BACK ON AND RESET. · SOMETIMES WILL JUST NOT INFUSE DESPITE EVERYTHING BEING CORRECT. NEED TO TURN OFF AND ON SEVERAL TIMES BEFORE IT EITHER STARTS WORKING OR NEED TO JUST NOT USE PUMP AND RUN BY GRAVITY. PUMP SN: (B)(6) - MDR#: 9610825-2025-00681. PUMP SN: (B)(6) - MDR#: 9610825-2025-00682.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23610207 ↗
  • MalfunctionNov 19, 2025False Alarm; Failure to Charge; Failure to Pump; False Alarm; Failure to Charge; Failure to Pump

    AS REPORTED BY THE USER FACILITY: THESE ARE THE ISSUES WITH THE 3 PUMP BEING REPORTED: SERIAL NR#'S (B)(6). PUMPS DO NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT CONTINUOUSLY SAY 'OCCLUSION' OR 'AIR IN LINE' DESPITE NEITHER OF WHICH REALLY PRESENT WHEN PRESSING START FOR INFUSION, FREQUENTLY WILL FLASH FROM SEVERAL DIFFERENT SCREENS RANDOMLY AND SUDDENLY NOT WORK. NEED TO TURN OFF AND BACK ON AND RESET SOMETIMES WILL JUST NOT INFUSE DESPITE EVERYTHING BEING CORRECT. NEED TO TURN OFF AND ON SEVERAL TIMES BEFORE IT EITHER STARTS WORKING OR NEED TO JUST NOT USE PUMP AND RUN BY GRAVITY. PUMP SN: (B)(6) - MDR#: 9610825-2025-00680. PUMP SN: (B)(6) - MDR#: 9610825-2025-00682.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23593882 ↗
  • MalfunctionNov 12, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    AS REPORTED BY THE USER FACILITY: REPORTER STATED THAT THE PUMP APPEARED TO HAVE OVER-INFUSED. THE BIOLOGIC ADMINISTERED WAS TYSABRI FOR MULTIPLE SCLEROSIS. THE INFUSION WAS INTENDED TO DELIVER A 100 ML BAG OVER ONE HOUR. WHEN THE INFUSION TIMER STOPPED, THERE WERE 20 MINUTES REMAINING, AND THE PUMP INDICATED 40 ML LEFT; HOWEVER, THE BAG WAS COMPLETELY EMPTY. THE PATIENT REMAINED STABLE AND WAS MONITORED FOR ONE HOUR POST-INFUSION DUE TO THE POTENTIAL FOR SEVERE SIDE EFFECTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23533151 ↗
  • MalfunctionNov 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: UNDER INFUSION - (NO PATIENT INJURY / NO ADDITIONAL DETAILS PROVIDED).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23453019 ↗
  • MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION VOLUME PROGRAMMED IN VISTA BASIC DOES NOT CORRESPOND WITH THE ACTUAL VOLUME DELIVERED; FOR INSTANCE, IF IT IS SET TO DELIVER 500 MILLILITERS (ML), IT MAY ONLY INFUSE 400ML. THIS HAPPENED TO SEVERAL OF OUR PATIENTS (THEIR IVIG IS ORDERED TO RUN OVER A RANGE OF TIME, USUALLY 2-4 HOURS, AND THIS RESULTED IN A SLIGHT DELAY. THIS WAS ADJUSTED BY ADDING TIME TO THE PUMPS AND THE INFUSION WAS ABLE TO RUN WITHOUT FURTHER ISSUE, BUT NOT AT THE TIME THAT WAS INITIALLY PROGRAMMED/INTENDED). REFERENCE MDR ID 9610825-2025-00051 AND 9610825-2025-00065 FOR OTHER ASSOCIATED EVENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21351203 ↗
  • MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION VOLUME PROGRAMMED IN VISTA BASIC DOES NOT CORRESPOND WITH THE ACTUAL VOLUME DELIVERED; FOR INSTANCE, IF IT IS SET TO DELIVER 500 MILLILITERS (ML), IT MAY ONLY INFUSE 400ML. THIS HAPPENED TO SEVERAL OF OUR PATIENTS (THEIR IVIG IS ORDERED TO RUN OVER A RANGE OF TIME, USUALLY 2-4 HOURS, AND THIS RESULTED IN A SLIGHT DELAY. THIS WAS ADJUSTED BY ADDING TIME TO THE PUMPS AND THE INFUSION WAS ABLE TO RUN WITHOUT FURTHER ISSUE, BUT NOT AT THE TIME THAT WAS INITIALLY PROGRAMMED/INTENDED). REFERENCE MDR ID 9610825-2025-00051 AND 9610825-2025-00064 FOR OTHER ASSOCIATED EVENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21351202 ↗
  • MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION VOLUME PROGRAMMED IN VISTA BASIC DOES NOT CORRESPOND WITH THE ACTUAL VOLUME DELIVERED; FOR INSTANCE, IF IT IS SET TO DELIVER 500 MILLILITERS (ML), IT MAY ONLY INFUSE 400ML. THIS HAPPENED TO SEVERAL OF OUR PATIENTS (THEIR IVIG IS ORDERED TO RUN OVER A RANGE OF TIME, USUALLY 2-4 HOURS, AND THIS RESULTED IN A SLIGHT DELAY. THIS WAS ADJUSTED BY ADDING TIME TO THE PUMPS AND THE INFUSION WAS ABLE TO RUN WITHOUT FURTHER ISSUE, BUT NOT AT THE TIME THAT WAS INITIALLY PROGRAMMED/INTENDED). REFERENCE MDR ID 9610825-2025-00064 AND 9610825-2025-00065 FOR OTHER ASSOCIATED EVENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21349363 ↗
  • MalfunctionJan 30, 2025Infusion or Flow Problem; Infusion or Flow Problem

    AS REPORTED BY THE USER FACILITY: NOT RUNNING CORRECTLY, RUNNING AT A FASTER RATE THAN PROGRAMMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21275651 ↗
  • MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

    AS REPORTED BY THE SALES REPRESENTATIVE: HE REPORTED THAT THE CUSTOMER HAS REPORTED FIVE INCIDENTS WERE THE DEVICES HAVE MALFUNCTION AS DESCRIBED. AS A RESULT, THE SALES REPRESENTATIVE WENT ON SITE TO HELP TROUBLE SHOOT (A NEW NURSE WHO HAD NOT USED THE PUMPS IN THE PAST WAS THE INITIAL REPORTER). THE SALES REPRESENTATIVE TESTED THE PUMPS USING SALINE AND COULD NOT REPLICATE THE REPORTED EVENT. THERE WERE LITTLE BUBBLES OBSERVED AS WELL AS BIG BUBBLES OBSERVED AND THE PUMP FUNCTION AS INTENDED. THE SALES REPRESENTATIVE POINTED OUT THAT THE CUSTOMER DID MENTION THAT THEY ARE PROGRAMMING THE INFUSIONS TO ACCOUNT FOR THE BAG VOLUME AND HAVE BEEN INCLUDING THE 10% OVERFILL. THE SALES REPRESENTATIVE ADVISED THAT THEY SHOULD INFUSE ONLY FOR THE CORRECT VOLUME AND THEN RE-RUN THE INFUSION IF THERE ARE RESIDUAL AMOUNTS IN THE BAG. THE CUSTOMER STRESSED THAT SALINE WORKS FINE, BUT IT IS WHEN THEY USE CISPLATIN AND LEUCOVORIN THAT THEY ENCOUNTER THE ISSUE. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THE REPORTED EVENT OCCURRED THREE TIMES WITH THE USE OF SERIAL NUMBER (B)(6). THIS REPORT IS FOR EVE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20684440 ↗
  • MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

    AS REPORTED BY THE SALES REPRESENTATIVE: HE REPORTED THAT THE CUSTOMER HAS REPORTED FIVE INCIDENTS WERE THE DEVICES HAVE MALFUNCTION AS DESCRIBED. AS A RESULT, THE SALES REPRESENTATIVE WENT ON SITE TO HELP TROUBLE SHOOT (A NEW NURSE WHO HAD NOT USED THE PUMPS IN THE PAST WAS THE INITIAL REPORTER). THE SALES REPRESENTATIVE TESTED THE PUMPS USING SALINE AND COULD NOT REPLICATE THE REPORTED EVENT. THERE WERE LITTLE BUBBLES OBSERVED AS WELL AS BIG BUBBLES OBSERVED AND THE PUMP FUNCTION AS INTENDED. THE SALES REPRESENTATIVE POINTED OUT THAT THE CUSTOMER DID MENTION THAT THEY ARE PROGRAMMING THE INFUSIONS TO ACCOUNT FOR THE BAG VOLUME AND HAVE BEEN INCLUDING THE 10% OVERFILL. THE SALES REPRESENTATIVE ADVISED THAT THEY SHOULD INFUSE ONLY FOR THE CORRECT VOLUME AND THEN RE-RUN THE INFUSION IF THERE ARE RESIDUAL AMOUNTS IN THE BAG. THE CUSTOMER STRESSED THAT SALINE WORKS FINE, BUT IT IS WHEN THEY USE CISPLATIN AND LEUCOVORIN THAT THEY ENCOUNTER THE ISSUE. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THE REPORTED EVENT OCCURRED THREE TIMES WITH THE USE OF SERIAL NUMBER (B)(6). THIS REPORT IS FOR EVE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20684431 ↗
  • MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

    AS REPORTED BY THE SALES REPRESENTATIVE: HE REPORTED THAT THE CUSTOMER HAS REPORTED FIVE INCIDENTS WERE THE DEVICES HAVE MALFUNCTION AS DESCRIBED. AS A RESULT, THE SALES REPRESENTATIVE WENT ON SITE TO HELP TROUBLE SHOOT (A NEW NURSE WHO HAD NOT USED THE PUMPS IN THE PAST WAS THE INITIAL REPORTER). THE SALES REPRESENTATIVE TESTED THE PUMPS USING SALINE AND COULD NOT REPLICATE THE REPORTED EVENT. THERE WERE LITTLE BUBBLES OBSERVED AS WELL AS BIG BUBBLES OBSERVED AND THE PUMP FUNCTION AS INTENDED. THE SALES REPRESENTATIVE POINTED OUT THAT THE CUSTOMER DID MENTION THAT THEY ARE PROGRAMMING THE INFUSIONS TO ACCOUNT FOR THE BAG VOLUME AND HAVE BEEN INCLUDING THE 10% OVERFILL. THE SALES REPRESENTATIVE ADVISED THAT THEY SHOULD INFUSE ONLY FOR THE CORRECT VOLUME AND THEN RE-RUN THE INFUSION IF THERE ARE RESIDUAL AMOUNTS IN THE BAG. THE CUSTOMER STRESSED THAT SALINE WORKS FINE, BUT IT IS WHEN THEY USE CISPLATIN AND LEUCOVORIN THAT THEY ENCOUNTER THE ISSUE. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THE REPORTED EVENT OCCURRED THREE TIMES WITH THE USE OF SERIAL NUMBER (B)(6). THIS REPORT IS FOR EVE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20684429 ↗
  • MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

    VISTA BASIC PUMP DID NOT ALARM FOR AIR THAT WENT PAST PUMP TO PATIENT, ON A COUPLE OF OCCASIONS INFUSING CISPLATIN AND LEUCOVORIN THE PUMP DID NOT ALARM FOR AIR ALMOST REACHING THE PATIENT. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6) (3 EVENTS). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THIS REPORT IS FOR SERIAL NUMBER (B)(6). REFER TO MANUFACTURER REPORT 9610825-2024-00805 FOR SERIAL NUMBER (B)(6). REFER TO MANUFACTURER REPORTS 9610825-2024-00802 (B)(6) AND FOR THE THREE EVENTS INVOLVING SERIAL NUMBER (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20683990 ↗
  • MalfunctionNov 12, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

    VISTA BASIC PUMP DID NOT ALARM FOR AIR THAT WENT PAST PUMP TO PATIENT, ON A COUPLE OF OCCASIONS INFUSING CISPLATIN AND LEUCOVORIN THE PUMP DID NOT ALARM FOR AIR ALMOST REACHING THE PATIENT. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6) (3 EVENTS), (B)(6) & (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. REPORT FOR SERIAL # (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20662219 ↗
  • MalfunctionOct 31, 2024Failure to Charge; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Failure to Charge; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: UNIT REPORTED TO BE CAUSING INACCURATE INFUSION RATES AND NEEDING A BATTERY REPLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20577398 ↗
  • MalfunctionOct 25, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: LIMITED INFORMATION WAS PROVIDED, HOWEVER, AN UNDER INFUSION ISSUE WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20531898 ↗
  • MalfunctionJul 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    THE INFUSION WAS PROGRAMMED FOR TWO HOURS. AFTER 30 MINUTES, THE BAG LOOKED MORE THAN HALF EMPTY AND THE PUMP SAID THAT IT STILL HAS AN HOUR AND A HALF TO GO. THE STAFF CLAMPED OFF THE BAG, SWITCHED OUT PUMPS AND THEN INFUSED THE REST OF THE MEDICATION REALLY SLOW TO TOTAL OUT TWO HOURS AND MONITORED THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19819891 ↗
  • MalfunctionJul 23, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    100ML BAG OVER 2.5 HRS PUMP WAS SET AT 40ML/HR FOR 2.5 HRS, IT SEEMED TO BE RUNNING FINE AND THEN AT THE 1 HOUR MARK IT RAN THE REST IN ABOUT 30 MINUTES. THE FLOW RATE ON THE PUMP DIDN'T CHANGE BUT IT RAN THROUGH THE REMINDER EXTREMELY FAST.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19811996 ↗
  • MalfunctionJul 23, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    PUMP WAS SET AT 40ML/HR FOR 2.5 HRS, IT SEEMED TO BE RUNNING FINE AND THEN AT THE 1 HOUR MARK IT RAN THE REST IN ABOUT 30 MINUTES. THE FLOW RATE ON THE PUMP DIDN'T CHANGE BUT IT RAN THROUGH THE REMINDER EXTREMELY FAST.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19811784 ↗
  • MalfunctionMar 12, 2024Improper Flow or Infusion; Fail-Safe Did Not Operate; Improper Flow or Infusion; Fail-Safe Did Not Operate

    AS REPORTED BY THE USER FACILITY: ISSUE WITH AIR SENSOR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18887878 ↗
  • MalfunctionJan 30, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    AS REPORTED BY THE USER FACILITY: WHILE RUNNING TEST ON THE PUMP CUSTOMER NOTICED THAT PUMP WAS OVERINFUSING - NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16263364 ↗
  • MalfunctionJan 6, 2023Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

    AS REPORTED BY THE USER FACILITY: "DURING THE PM INSPECTION, I NOTICED THAT THE IV PUMP WAS DELIVERING TOO FAST. THE IV PUMP WAS NOT ON A PATIENT AND THERE IS NO PATIENT INVOLVEMENT".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16111986 ↗
  • MalfunctionAug 30, 2022Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: "MALFUNCTION CODE 108 FF1.6. INFUSIONS RUNNING SLOW. (WHEN I TURNED IT ON THERE WAS NO MALFUNCTION CODE PRESENT, HOWEVER THE PUMP HAD BEEN TURNED OFF AND UNPLUGGED FOR".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15325385 ↗
  • MalfunctionMar 23, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    AS REPORTED BY THE USER FACILITY: THE PATIENT WAS GETTING ENTYVIO WHICH IS MIXED IN A BAG OF 250CC OF SALINE. THE INFUSION RATE WAS 518 OVER 30 MINUTES. ABOUT 15 MINUTES INTO THE INFUSION IT WAS DISCOVERED THAT THE RATE ON THE PUMP HAD DROPPED DOWN TO 250 AND IT DID IT ON ITS OWN. PATIENT BROUGHT IT TO OUR ATTENTION AS THEY NOTICED THAT THE PUMP WAS NOT RUNNING AT THE REGULAR RATE. THERE WAS NO HARM BROUGHT TO THE PATIENT BUT THIS HAD HAPPENED BEFORE. WE HAD TO CLOSELY MONITOR THE PUMP AND IT HAPPENED AGAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13869102 ↗
  • MalfunctionFeb 8, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    AS REPORTED BY THE USER FACILITY: "INFUSIONS ARE GOING IN TWICE AS FAST AS THEY SHOULD. LITERALLY A 4 MIN INFUSION FINISHED IN 2 MINUTES WITH THE PATIENTS GETTING EXTREME SIDE EFFECTS." NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13480309 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.