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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE CORPORATION BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number FMC9673
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the air vent of a blood administration pump set flew off when the air vent flap was opened.It was further reported that blood was observed dripping out from the air vent outlet.This was identified during priming the set with the blood product.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph using the naked eye which revealed that the air vent was missing from the chamber.The reported condition was verified.By the nature of the sample, no additional tests were performed.The cause of the condition was due to a manufacturing issue.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
BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10953309
MDR Text Key220252398
Report Number1416980-2020-07576
Device Sequence Number1
Product Code BRZ
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 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFMC9673
Device Lot Number19J08T240
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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