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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 01/19/2024
Event Type  malfunction  
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 several secukit ci-ca hd 1000 connectors broke during a patient's continuous renal replacement therapy (crrt) and needed to be changed.During the first occurrence there was a crack noted in the blue luer connector connected to the patient's dialysis catheter (not a fresenius product) as if the plastic was too hard and brittle.The nurse discovered upon returning the patient's blood that the tube could not be attached to the saline bag and noticed the connection was loose.Later, the patient's cannula (not a fresenius product) underwent reconstruction, and there was a pause in treatment when again the luer of the arterial tube cracked when reconnecting to the saline bag.Three or four kits have broken in a row at the same connection at the ends of the blood tubes.The nurse stated that the staff is experienced with the product and this is not the result of user error.It was noted that transoperable caps were used in the patient's catheter in some of the instances where the connector cracked.Blood loss was reported.The patient's estimated blood loss (ebl) is approximately 300 ml.There was no serious injury or required medical intervention as a result of the reported issue.One of the samples was reported to be available to be returned to the manufacturer for physical evaluation.
 
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 several secukit ci-ca hd 1000 connectors broke during a patient's continuous renal replacement therapy (crrt) and needed to be changed.During the first occurrence there was a crack noted in the blue luer connector connected to the patient's dialysis catheter (not a fresenius product) as if the plastic was too hard and brittle.The nurse discovered upon returning the patient's blood that the tube could not be attached to the saline bag and noticed the connection was loose.Later, the patient's cannula (not a fresenius product) underwent reconstruction, and there was a pause in treatment when again the luer of the arterial tube cracked when reconnecting to the saline bag.Three or four kits have broken in a row at the same connection at the ends of the blood tubes.The nurse stated that the staff is experienced with the product and this is not the result of user error.It was noted that transoperable caps were used in the patient's catheter in some of the instances where the connector cracked.Blood loss was reported.The patient's estimated blood loss (ebl) is approximately 300 ml.There was no serious injury or required medical intervention as a result of the reported issue.One of the samples was reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Correction: b5 (patient's estimated blood loss (ebl), discontinuation of treatment, sample availability).
 
Event Description
A user facility nurse reported to fresenius that several secukit ci-ca hd 1000 connectors broke during a patient's continuous renal replacement therapy (crrt) and needed to be changed.During the first occurrence there was a crack noted in the blue luer connector connected to the patient's dialysis catheter (not a fresenius product) as if the plastic was too hard and brittle.The nurse discovered upon returning the patient's blood that the tube could not be attached to the saline bag and noticed the connection was loose.Later, the patient's cannula (not a fresenius product) underwent reconstruction, and there was a pause in treatment when again the luer of the arterial tube cracked when reconnecting to the saline bag.Three or four kits have broken in a row at the same connection at the ends of the blood tubes.The nurse stated that the staff is experienced with the product and this is not the result of user error.It was noted that transoperable caps were used in the patient's catheter in some of the instances where the connector cracked.Blood loss was reported.The patient's estimated blood loss (ebl) is approximately 246 ml.There was no serious injury or required medical intervention as a result of the reported issue.The patient's treatment was reported to be discontinued.There are no samples reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: the complaint sample was not available to be returned to the manufacturer for physical evaluation.Retention sample analysis was performed.A visual inspection occurred where the samples were checked for component defect, conformity with the product specification.A leakage test was completed under air/liquid pressure for assembly failure and leakage.No failures were detected within the retained samples.The cause of the reported issue could not be established in the absence of the actual complaint device.A batch records review was performed.It was conducted that 840 units were inspected according to protocol and found to be performing to specifications.No indication for any relation with the reported failure mode has been found during the review.
 
Event Description
A user facility nurse reported to fresenius that several secukit ci-ca hd 1000 connectors broke during a patient's continuous renal replacement therapy (crrt) and needed to be changed.During the first occurrence there was a crack noted in the blue luer connector connected to the patient's dialysis catheter (not a fresenius product) as if the plastic was too hard and brittle.The nurse discovered upon returning the patient's blood that the tube could not be attached to the saline bag and noticed the connection was loose.Later, the patient's cannula (not a fresenius product) underwent reconstruction, and there was a pause in treatment when again the luer of the arterial tube cracked when reconnecting to the saline bag.Three or four kits have broken in a row at the same connection at the ends of the blood tubes.The nurse stated that the staff is experienced with the product and this is not the result of user error.It was noted that transoperable caps were used in the patient's catheter in some of the instances where the connector cracked.Blood loss was reported.The patient's estimated blood loss (ebl) is approximately 300 ml.There was no serious injury or required medical intervention as a result of the reported issue.One of the samples was reported to be available to be returned to the manufacturer for physical evaluation.
 
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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 Key18684362
MDR Text Key335198142
Report Number0001225714-2024-00007
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeFI
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,Followup,Followup
Report Date 05/02/2024
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
Device Lot NumberE9UC064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 01/23/2024
Initial Date FDA Received02/12/2024
Supplement Dates Manufacturer Received02/14/2024
02/23/2024
04/30/2024
Supplement Dates FDA Received02/19/2024
03/01/2024
05/01/2024
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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