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 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the access line into the vascular catheter snapped off after about four to five days of continuous veno-venous hemodialysis (cvvhd) treatment.As a result, the patient required a new vascular catheter to be inserted which delayed the restart of treatment.The reported event resulted in approximately 200 ml (or less) of blood loss.The access line is a component of the multifiltratepro secucas ci-ca hd cassette.The vascular catheter is not a product manufactured by fresenius.When the line snapped off, there was no alarm from the machine.The patient was being treated on a multifiltratepro machine.There was no report of any fluid leak occurring.Upon follow-up, it was stated that an unspecified defect or irregularity was noticed by the user when they attempted to disconnect the access line.The location of the defect or irregularity was not stated.There were no other issues leading up to the event.There was no harm to the patient, and treatment was continued.The broken luer lock (which had snapped off and remained in the access line) was removed, and the line was used for cvvhd the next day.As a side note, it was reported that the patient later died due to an underlying multi-organ failure.However, there was no indication that the patient was undergoing treatment at the time of their death, nor was there any allegation that a fresenius product deficiency or malfunction may have caused or contributed to the event.No sample was available to be returned for evaluation.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that the access line into the vascular catheter snapped off after about four to five days of continuous veno-venous hemodialysis (cvvhd) treatment.As a result, the patient required a new vascular catheter to be inserted which delayed the restart of treatment.The reported event resulted in approximately 200 ml (or less) of blood loss.The access line is a component of the multifiltratepro secucas ci-ca hd cassette.The vascular catheter is not a product manufactured by fresenius.When the line snapped off, there was no alarm from the machine.The patient was being treated on a multifiltratepro machine.There was no report of any fluid leak occurring.Upon follow-up, it was stated that an unspecified defect or irregularity was noticed by the user when they attempted to disconnect the access line.The location of the defect or irregularity was not stated.There were no other issues leading up to the event.There was no harm to the patient, and treatment was continued.The broken luer lock (which had snapped off and remained in the access line) was removed, and the line was used for cvvhd the next day.As a side note, it was reported that the patient later died due to an underlying multi-organ failure.However, there was no indication that the patient was undergoing treatment at the time of their death, nor was there any allegation that a fresenius product deficiency or malfunction may have caused or contributed to the event.No sample was available to be returned for evaluation.

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.

• 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: 18897327
• MDR Text Key: 337588576
• Report Number: 0001225714-2024-00026
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: D9UK22300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/22/2024
• 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
• Treatment: FRESENIUS EMIC2 DIALYZER; FRESENIUS EMIC2 DIALYZER; FRESENIUS MULTIFILTRATEPRO MACHINE; FRESENIUS MULTIFILTRATEPRO MACHINE
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 88 KG