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

Catalog Number 36-2438-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to fresenius that an external leak occurred five hours into a patient's continuous veno-venous hemodiafiltration (cvv[hdf]) therapy.The leak was coming from the pre-filter dome of the multifiltrate pro hdf cassette.Photos of the leak were provided for review.The event resulted in approximately 50 ml or less of blood loss.No medical intervention was required due to the event.The sample was not available to be returned for evaluation.No further details were provided in the initial reporting.

Event Description

A communication was received from the country complaint administrator (cca) which stated the customer does not remember the event.The cca did their best to provide additional details based on what they knew.No alarm occurred - the customer simply noticed there was an external leak.The cca assumed the treatment was being performed on a fresenius multifiltratepro machine with an ultraflux av 600s dialyzer.The cca said maybe there was a little gap on the connector between the main tube and prefilter pressure dome.It was confirmed that the treatment was temporarily interrupted to remove the cassette from the machine.It was unknown if the patient was re-setup with new supplies, or if they completed their treatment.The cca stated there was no patient injury or harm, and the patient did not require medical intervention.

Manufacturer Narrative

Additional information: b5, d10 plant investigation: the complaint sample was not available for evaluation.An examination was performed on the retained samples.The samples were checked for component defects, assembly failures, and conformity with product specifications.The samples were also subjected to leakage testing under air/liquid pressure to inspect for leaks and other assembly failures.No failures were detected during examination of the retained samples.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.A batch record review was performed, and batch production records were found to be conforming.No non-conformities were observed during the manufacturing process.The exact reason for the defect cannot be determined without an evaluation of the actual sample.Possible reasons for the defect could be related to a component defect on the pressure dome, improper connection of the pressure dome to machine, or the user handling process.The production department has been informed of this defect.

• 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 Key: 18239870
• MDR Text Key: 329395663
• Report Number: 0001225714-2023-00097
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 01/12/2024

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: 36-2438-0
• Device Lot Number: D9UM151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/11/2024
• 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: MULTIFILTRATE PRO MACHINE; ULTRAFLUX DIALYZER