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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C2009K
Device Problem Filling Problem (1233)
Patient Problems Diarrhea (1811); Fatigue (1849); Vomiting (2144)
Event Date 03/11/2021
Event Type  Injury  
Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient experienced an over infusion with a large volume infusor which resulted in weakness, vomiting and diarrhea.It was reported the infusion was completed in 24 hours instead of the expected 48 hours.It was reported the device contained 3400 mg of fluorouracil (68ml) and 162 ml of dextrose 5% for a final volume of 230 ml.The infusor is indicated to contain a fill volume of 250 ml.The cause of the over infusion was not reported.It was reported the patient presented to the emergency room and was subsequently hospitalized for the events.The patient was treated with unspecified antiemetics, loperamide and vistogard.It was reported the patient was discharged from the hospital.At the time of this report, the patient outcome was not reported.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation with no fluid in the bladder.Visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional flow rate testing was performed by filling the device with dextrose solution and allowing the device to flow.The device¿s flow rate during the functional flow rate test was found to be within the product flow rate specification range.The reported condition was not verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
INFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11614700
MDR Text Key243791394
Report Number1416980-2021-01865
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412579399
UDI-Public(01)00085412579399
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/01/2023
Device Catalogue Number2C2009K
Device Lot Number20J008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Initial Date Manufacturer Received 03/15/2021
Initial Date FDA Received04/05/2021
Supplement Dates Manufacturer Received05/03/2021
Supplement Dates FDA Received05/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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