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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 IN2C1155KP
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a multirate infusor underinfused during a patient infusion.The expected therapy time was 46 hours.The reporter stated that after 48 hours, there was drug remaining in the device.The device had been filled with fluorouracil (5-fu).There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The lot was manufactured from october 25, 2018 - october 29, 2018.H0: the device was received for evaluation.A visual inspection was performed using the naked which eye did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate testing was performed with no issues noted; rate was found within specification range.The device was found to be conforming product.The reported condition was not verified.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 Key9513433
MDR Text Key172598538
Report Number1416980-2019-07133
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412517544
UDI-Public(01)00085412517544
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberIN2C1155KP
Device Lot Number18K036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Initial Date Manufacturer Received 11/30/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received01/08/2020
Supplement Dates FDA Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLUORURACIL
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