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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVAMED (ANTALYA) MULTIFILTRATEPRO HDF; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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NOVAMED (ANTALYA) MULTIFILTRATEPRO HDF; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 36-2438-0
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/10/2024
Event Type  malfunction  
Event Description
A user facility nurse reported to fresenius that a blood leak occurred during the patient's continuous renal replacement therapy (crrt) on the multifiltratepro machine.The reported issue occurred approximately two hours after treatment initiation.The blood leak occurred from the pre-filter (pressure dome).All pressure values were within the normal range.There was no serious injury of required medical intervention reported.The patient's estimated blood loss (ebl) was approximately 50 ml.Treatment was resumed after blood reinfusion.The sample was reported to be available for physical evaluation by the manufacturer.No additional information was provided.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A user facility nurse reported to fresenius that a blood leak occurred during the patient's continuous renal replacement therapy (crrt) on the multifiltratepro machine.The reported issue occurred approximately two hours after treatment initiation.The blood leak occurred from the pre-filter (pressure dome).All pressure values were within the normal range.There was no serious injury of required medical intervention reported.The patient's estimated blood loss (ebl) was approximately 50 ml.Treatment was resumed after blood reinfusion.The sample was reported to be available for physical evaluation by the manufacturer.No additional information was provided.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint sample was not returned to the manufacturer for physical evaluation.Examination of retained samples were completed in the place of a physical evaluation of the actual complaint sample.A visual inspection was performed where the samples were checked for component defects, assembly failures, and overall conformity to product specification.A leakage test was also performed where the samples were checked under air/liquid pressure for assembly failure and leakage.No failures were detected during examination of the retained samples.The batch records were also reviewed.The records indicated that 2,640 units originated from this lot.The batch product record controls resulted with conformity.Non-conformity was not observed during the manufacturing process.The reported issue was confirmed by the manufacturer.However the cause of the reported issue could not be determined in the absence of the actual complaint sample.
 
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Brand Name
MULTIFILTRATEPRO HDF
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
NOVAMED (ANTALYA)
antalya freezone ctr branch
liman s b mah.4. sk.no:16
konyaalti-antalya 07070
TU  07070
Manufacturer (Section G)
NOVAMED (ANTALYA)
antalya freezone ctr branch
liman s b mah.4. sk.no:16
konyaalti-antalya 07070
TU   07070
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key19003929
MDR Text Key339154833
Report Number0001225714-2024-00031
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
EUA200149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number36-2438-0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received04/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MULTFILTRATEPRO MACHINE.; MULTFILTRATEPRO MACHINE.
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