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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that an external leak occurred one hour into a patient's continuous renal replacement therapy (crrt).The leak came from the pre-filter pressure dome of a multfiltrate pro hdf1000.There was no history of a machine alarm.The patient's blood was not returned.The estimated blood loss was approximately 216 ml.It was reported there was no change in the patient's medical condition.The patient did not receive any medical intervention due to the blood loss.The patient's treatment was continued after the clinic nurse replaced the crrt kit.The kit that leaked was reportedly discarded.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

Manufacturer Narrative

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

Manufacturer Narrative

Plant investigation: the complaint sample was not available for evaluation.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.Retention samples were found to be conforming to product specifications.A review was conducted on the batch related documents and device history records (dhr).The review did not show any non-conformities or abnormalities.During the review, no indication for any relationship with the reported failure mode was found.The manufacturing processes and production records were also checked and found to be conforming.Based on the available information, the cause of the defect is associated to supplied material in which the problematic component (pressure dome) has been taken into consideration.The supplier has been aware of the situation and taken action to correct the cause of failure, and those actions were covered in a quality event by the supplier.

Event Description

It was reported that an external leak occurred one hour into a patient's continuous renal replacement therapy (crrt).The leak came from the pre-filter pressure dome of a multfiltrate pro hdf1000.There was no history of a machine alarm.The patient's blood was not returned.The estimated blood loss was approximately 216 ml.It was reported there was no change in the patient's medical condition.The patient did not receive any medical intervention due to the blood loss.The patient's treatment was continued after the clinic nurse replaced the crrt kit.The kit that leaked was reportedly discarded.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

• 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: 15589007
• MDR Text Key: 303236151
• Report Number: 0001225714-2022-00006
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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: B9UI254
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/11/2023
• 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