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 03/22/2024

Event Type  malfunction  

Event Description

It was reported that a multifiltrate pro secucas ci-ca hd connector was noted to be broken at the end of a patient¿s continuous renal replacement therapy (crrt) treatment.The patient experienced approximately 500 ml of blood loss.Upon follow up it was confirmed that there was no system alarm.The crack was noticed immediately as the set was connected to the saline bag.The kit was exchanged due to the crack.The patient¿s treatment was restarted and completed on the same machine.There was no patient injury or medical intervention due to the reported event.The sample was reported to be available for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the complaint sample was not received for evaluation.Batch production record controls resulted in conformity.Non-conformity was not observed during manufacturing process.Complaint history review confirmed other complaints reported against the lot.The reported event is adequately addressed in the instructions for use.There is no indication that the reported failure relates to falsification.Retained sample examination resulted in no failure, leakage test resulted in conformity and the samples were found as conform with the technical drawing.Possible reasons for the reported defect might be related to component defect, assembly failure or connection failures but not limited to.The reported event was admitted, however exact reason of the defect could not be determined due to absence of the original sample.

Event Description

It was reported that a multifiltrate pro secucas ci-ca hd connector was noted to be broken at the end of a patient¿s continuous renal replacement therapy (crrt) treatment.The patient experienced approximately 500 ml of blood loss.Upon follow up it was confirmed that there was no system alarm.The crack was noticed immediately as the set was connected to the saline bag.The kit was exchanged due to the crack.The patient¿s treatment was restarted and completed on the same machine.There was no patient injury or medical intervention due to the reported event.The sample was reported to be available for evaluation.

• 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: 19038063
• MDR Text Key: 339336827
• Report Number: 0001225714-2024-00032
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 05/02/2024

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: 36-8116-0
• Device Lot Number: E9UC035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/02/2024
• 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
• Treatment: MULTIFILTRATEPRO MACHINE.; MULTIFILTRATEPRO MACHINE.