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 12/03/2023

Event Type  malfunction  

Event Description

It was reported that a multifiltrate pro secucas ci-ca hd had a blood leak that occurred in the tubing system (pre-filter pressure dome) 72 hours into a patient¿s continuous renal replacement therapy (crrt) treatment.The patient experienced approximately 200 ml of blood loss.The sample was reported to be available for evaluation.Additional information requested but has not been obtained.

Manufacturer Narrative

Investigation: machine files were not provided for investigation.Original sample was available and analyzed accordingly.Review of device history record (dhr) revealed batch production record controls resulted with conformity.Non-conformity was not observed during manufacturing process.A 100% testing of each machine ensures that devices are delivered according to specifications.A blood contaminated mfc bloodline without blister package was received for investigation.Visual inspection: the sample was checked for component defect, conformity with the product specification.Leakage test: the sample was checked under air/liquid pressure for assembly failure and leakage.Review of instruction for use (ifu) and/or label noted that the described situation is adequately addressed in ifu and/or on the label.There is no indication that the reported failure relates to falsification.No information found that product is related to falsification or an unauthorized configuration.As result of examination, it was observed that there was rupture causing leakage on the membrane of the pressure dome.The complaint was admitted, however exact reason of the defect could not be determined.Raw material-based defect, improper connection of the pressure dome or handling process during treatment may be considered as possible reasons, but not limited to.

• 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: 18866753
• MDR Text Key: 337229663
• Report Number: 0001225714-2024-00024
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: E9UC064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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