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 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: a product sample was not returned for evaluation.Product batch information was reviewed, and no non-conformities were observed during the manufacturing process.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.A product examination was performed on the retained samples.The samples underwent a visual inspection and a leakage test.They were checked for component defects, assembly failures, and to verify conformity with product specifications.The samples were then subjected to a leakage test where air/liquid pressure was applied to check for leaks and other assembly failures.No failures were detected on the retained samples.The exact cause for the failure could not be determined due to the absence of an actual sample.Based on the available information, here are some of the possible causes: a component defect on the connector (raw material defect), assembly failure between the tub and connector due to nonconforming tube dimensions (external diameter or wall thickness), a nonconformity in the assembly process, or an improper connection of the connector to the filter.The production department has been informed of the defect.

Event Description

It was reported that a leak occurred 45-hours into a patient¿s 72-hour planned continuous veno-venous hemodialysis (cvvhd) treatment.The nurse noticed fluid dripping from the bottom of the dialyzer.It was also reported that a transmembrane pressure alarm occurred.The dialyzer was inspected prior to use and no structural damage or other defects were noted.The treatment was discontinued and most of the patient¿s blood was rinsed back.The estimated blood loss (ebl) due to the events was unknown.Upon follow-up, it was reported that the leaking fluid was dialysate.It was later indicated that the leak was suspected to be coming from the dialysate port connector.The patient did not experience any adverse effects, nor did they require medical intervention.It was reported that the sample was not available to be returned for evaluation.

• 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: 18576773
• MDR Text Key: 333822780
• Report Number: 0001225714-2024-00004
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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: D9UC283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/28/2023
• 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: ULTRAFLUX DIALYZER.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 54 KG