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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); Leak/Splash (1354); Protective Measures Problem (3015)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
According to the reporter, 3 hours at the start of hdf (hemodiafiltration) for the patient with end stage renal disease, the nurse noticed a blood leak at the top welding seam of the dialyzer. The place where the potting (top and bottom) of the dialyzer is welded on the dialyzer itself where the blood came in from the connected bloodline. There was no defects/damages found on the product. There was a blood leakage alarm activated. It was also stated that there were blood transfusions done. Priming was done and the result was normal. There was nothing unusual observed on the device prior to use. Only the bloodline was the product being utilized with the device with nothing unusual detected. There was nothing other defects/damages found on the product where the leak was observed. There were no components replaced. Dialysis was successfully finished after the switch of the membrane. There was no patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13442837
MDR Text Key284988634
Report Number1000312731-2022-00002
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,Followup,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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 Received03/08/2022
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: 02/03/2022 Patient Sequence Number: 1
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