MAUDE Adverse Event Report: NOVAMED (ANTALYA) MULTIFILTRATEPRO SECUCAS CI-CA HD; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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.

• 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 Key: 18684362
• MDR Text Key: 335198142
• Report Number: 0001225714-2024-00007
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• 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 Number: 36-8116-0
• Device Lot Number: E9UC064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/14/2024; 02/23/2024; 04/30/2024
• Supplement Dates FDA Received: 02/19/2024; 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 Number: 1