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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELLCO SRL CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE

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BELLCO SRL CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE Back to Search Results
Model Number IBP4374
Device Problems Fluid Leak (1250); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 01/12/2022
Event Type  Injury  
Event Description
According to the reporter, approximately after three hours of hdf (hemodiafiltration) treatment, the nurse noted that there was a blood leak on the top of the dialysis at the weld seam without any detectable reason. It was also stated that the blood leakage alarm was activated and blood transfusion was required. There was no clinical outcome due to the event. There was no reported patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, approximately after three hours of hdf (hemodiafiltration) treatment, the nurse noted that there was a blood leak on the top of the dialysis at the weld seam without any detectable reason. It was also stated that the blood leakage alarm was activated and blood transfusion was required. There was no clinical outcome due to the event. There was no reported patient injury.
 
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Brand NameCLEARUM HS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE
Manufacturer (Section D)
BELLCO SRL
v camurana 1
mirandola,mo 41037
IT 41037
Manufacturer (Section G)
BELLCO SRL
v camurana 1
mirandola,mo 41037
IT 41037
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key13620945
MDR Text Key286267826
Report Number1000312731-2022-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K193542
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIBP4374
Device Catalogue NumberIBP4374
Device Lot Number2110000530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/28/2022 Patient Sequence Number: 1
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