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 10/18/2023

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 that a multifiltrate pro hd had a blood leak through pressure dome 12 hours into a patient¿s continuous renal replacement therapy (crrt) treatment.The patient¿s blood was not returned, and as a result they experienced approximately 50 ml of blood loss.The sample was reported to not be available for evaluation.

Manufacturer Narrative

Investigation: the complaint sample was not available for evaluation.Product batch production record controls resulted with conformity.Nonconformity was not observed during manufacturing process.There is no other complaint reported during complaint history review.The reported event is adequately documented in the instructions for use and/or the label.There is no indication that the reported failure relates to falsification.The retained samples were checked for defect, assembly failure, and leakage test which resulted in conformity.The reported event was not confirmed.

Event Description

It was reported that a multifiltrate pro hd had a blood leak through pressure dome 12 hours into a patient¿s continuous renal replacement therapy (crrt) treatment.The patient¿s blood was not returned, and as a result they experienced approximately 50 ml of blood loss.The sample was reported to not be available 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: 18145212
• MDR Text Key: 328274895
• Report Number: 0001225714-2023-00092
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/02/2024
• 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