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 12/13/2023

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 with the arterial patient connector of the multifiltratepro hdf cassette during a patient's continuous renal replacement therapy (crrt) that resulted in blood loss.The reported issue was identified upon starting treatment.The leak occurred as the result of a crack.The patient's estimated blood loss (ebl) is approximately 50 ml.There was no serious injury or required medical intervention reported.The sample is not available to be returned to the manufacturer for physical evaluation.No additional information was provided.

Manufacturer Narrative

Plant investigation: the complaint sample was not returned to the manufacturer for physical examination.Retained samples were visually inspected for component defects and found to be conforming to specification.The retained samples were also tested under air and liquid pressures and no failure was detected.A review of the batch records was performed.(b)(4) products have originated from the lot that were inspected according to protocol and were found conforming to specification.The reported issue is confirmed however a cause for the reported issue could not be determined in the absence of the original complaint sample.

Event Description

It was reported to fresenius that an external leak occurred with the arterial patient connector of the multifiltratepro hdf cassette during a patient's continuous renal replacement therapy (crrt) that resulted in blood loss.The reported issue was identified upon starting treatment.The leak occurred as the result of a crack.The patient's estimated blood loss (ebl) is approximately 50 ml.There was no serious injury or required medical intervention reported.The sample is not available to be returned to the manufacturer for physical 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: 18788864
• MDR Text Key: 337532991
• Report Number: 0001225714-2024-00015
• 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: 05/31/2024

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: D9UL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• 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: MULTIFILTRATEPRO KIT; MULTIFILTRATEPRO KIT