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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 IBP4373
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Event Date 09/13/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, about 30 minutes after the beginning of the hemodialysis (hd) treatment, the patient was not well and had hypotension. The blood pressure was not available, the competitor's machine could not take the measurement and the nurse tried with 3 different blood pressure monitors. The patient was not responsive (faintness). The nurse tried a bolus of 200 ml of physiological saline as medical treatment, but it did not work. The nurse stopped the treatment and gave back the blood to the patient and after that, the hypotension was resolved, the machine could take the measurement, the patient was okay and recuperated. The doctor was not sure if the problem was linked to the dialyzer. They started another treatment with other brand on (b)(6) but the same symptoms occurred so they stopped the treatment and they decided to stop dialysis for this patient. It was also stated that the patient had just started the treatment by dialysis. Venous blood pressure was 145, arterial blood pressure was -190, blood flow rate (qb) was 240, infusion flow rate (qinf) was 0, dialysate flow rate (qd) was 500, tmp (trans membrane pressure) was -15, lovenox 0. 4 was the anticoagulant administered. There was no blood leak. No alarms activated. No visible damage and no problem to the cuff or on the machine. No components replaced. Nothing unusual observed on the device prior to treatment and the priming went well with no problem. No identifiable malfunction on the filter. No other products being utilized with the device. There was no blood loss and blood transfusion was not required. No additional medical treatments required to resolve the event.
 
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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
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key12556211
MDR Text Key274237189
Report Number1000312731-2021-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K193542
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIBP4373
Device Catalogue NumberIBP4373
Device Lot Number2107000300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2021
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: 09/30/2021 Patient Sequence Number: 1
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