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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVAMED (ANTALYA) MULTIFILTRATEPRO SECUCAS CI-CA HD; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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NOVAMED (ANTALYA) MULTIFILTRATEPRO SECUCAS CI-CA HD; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 36-8116-0
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
It was reported that the connection between the filtrate line and the bag snapped off after about four to five days of continuous veno-venous hemodialysis (cvvhd) treatment.The reported event resulted in approximately 200 ml (or less) of blood loss.The complaint sample was not available to be returned for evaluation.Multiple attempts have been made to obtain additional information, and thus far no further details have been provided.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
Plant investigation: the actual complaint sample was not returned for evaluation.However, a retention sample analysis was performed.A visual inspection was performed on the retained samples where they were checked for component defects.The samples passed the visual inspection and were found to be conforming with product specifications.The samples underwent leakage testing where air/liquid pressure was applied to check for leaks and/or connection failures.There were no failures detected on the retained samples.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.The product batch information was reviewed.Batch production record controls resulted with conformity.No nonconformities were observed during the manufacturing process.The exact reason for the product defect could not be determined without physical evaluation of the actual device.Based on the available information, the possible reasons for the defect may be related to the user handling process (overtightening of the connection or usage of external tool for connection etc.).The production department has been informed of the defect.
 
Event Description
It was reported that the connection between the filtrate line and the bag snapped off after about four to five days of continuous veno-venous hemodialysis (cvvhd) treatment.The reported event resulted in approximately 200 ml (or less) of blood loss.The complaint sample was not available to be returned for evaluation.Multiple attempts have been made to obtain additional information, and thus far no further details have been provided.
 
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Brand Name
MULTIFILTRATEPRO SECUCAS CI-CA HD
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 Key18909138
MDR Text Key337799734
Report Number0001225714-2024-00028
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUK
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 05/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number36-8116-0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/14/2024
Supplement Dates Manufacturer Received03/22/2024
Supplement Dates FDA Received05/17/2024
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
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