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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FOLFUSOR; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE CORPORATION FOLFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C4711K
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the ¿rubber membrane¿ (bladder) of a folfusor sv (small volume) 2.5 ml was torn at the time of filling.The device was filled with fluorine and glucose.This was identified prior to use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that the photograph showed evidence of a bladder rupture.The reported condition was 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
FOLFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12515688
MDR Text Key272905990
Report Number1416980-2021-05858
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412082172
UDI-Public(01)00085412082172
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 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C4711K
Device Lot Number21C049
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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