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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION FLOPUMP
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INTERNATIONAL BIOPHYSICS CORPORATION FLOPUMP Back to Search Results
Catalog Number 6400S-BRA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2021
Event Type  malfunction  
Manufacturer Narrative
Product has not been returned.If product is returned or additional infomration received, a supplemental report shall be submitted.
 
Event Description
Customer observed leaking from the centrifuge pump during the priming procedure.There was no contact with the patient, and was replaced before the procedure started.
 
Manufacturer Narrative
Product was received and evaluated and a small leak was found.There was no patient involvement.
 
Event Description
Customer observed leaking from the centrifuge pump during the priming procedure.There was no contact with the patient, and was replaced before the procedure started.
 
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Brand Name
FLOPUMP
Type of Device
FLOPUMP
Manufacturer (Section D)
INTERNATIONAL BIOPHYSICS CORPORATION
2101 e. st elmo road
suite 275
austin TX 78744
MDR Report Key11831716
MDR Text Key268444278
Report Number1645362-2021-00001
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K170029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2021
Device Catalogue Number6400S-BRA
Device Lot Number120219-8253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Date Manufacturer Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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