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 11/27/2023

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 white stripes in return tubing in the ci-ca cvvhd kit used in combination with ci-ca dialysate plus during the patient¿s continuous venovenous hemodialysis (cvvhd) treatment.The patient had high fibrinogen.The patient was disconnected from tubing and the treatment was restarted with new tubing and ci-ca dialysate.The patient¿s blood which resulted in approximately 200 ml of blood loss.The sample was reported to not be available for evaluation.Additional information requested but has not been obtained.

Event Description

Additional information received confirmed that the multifiltrate pro machine was used during treatment.The treatment was completed on the same machine, however a different kit and type of dialysate (without phosphate instead of phosphate-containing dialysate) was used.

Manufacturer Narrative

Investigation: the sample was not returned.Batch production record controls resulted with conformity.Nonconformity was not observed during manufacturing process.Complaint history review confirmed there was no other complaint reported for the batch.The reported event is adequately addressed in the instructions for use and/or the label.There is no indication that the reported failure relates to falsification.The retained samples evaluation confirmed there was no failure detected.According to the results of the production group investigation, no change was observed to the production or manufacturing processes.The complaint was admitted and associated to supplied material due to possible inadequate product design.

Event Description

Additional information received confirmed that the multifiltrate pro machine was used during treatment.The treatment was completed on the same machine, however a different kit and type of dialysate (without phosphate instead of phosphate-containing dialysate) was used.

• 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: 18493968
• MDR Text Key: 332767741
• Report Number: 0001225714-2024-00001
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 01/16/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/15/2024; 01/05/2024
• Supplement Dates FDA Received: 01/15/2024; 01/16/2024
• 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: MULTIFILTRATE PRO MACHINE.; MULTIFILTRATE PRO MACHINE.